The Sales Executive -Medical Devices Sector cultivates new business opportunities and develops long-term business partnerships with clients related to medical devices. Assesses customer needs, creates solutions based on the DNV product portfolio, including training and certification, EU requirements, US/MDSAP, ISO standards, and other complimentary schemes. Achieves a sales target and increases revenue through selling clients DNV solutions applicable for their businesses. Achieves sales revenue goals in India and other designated markets. Responsible for all sales activities to include certification, audits, training, and full solutions. Develops and implements agreed upon business/marketing plan which will meet business goals by expanding customer base. Establish rapport and liaison with Regulatory bodies and seek advance information on legal/regulatory introduction/amendments impacting DNV business. Collaborate with Digital Marketing Team to create digital marketing strategies, organize webinars, and follow up for conversion. Works along with the operations/ delivery teams for the achievement of customer satisfaction, revenue generation, and long-term overall account goals. Develops a database-maintained system of qualified leads attained through consultant referrals, face-to-face meetings, calls, direct mail, email, and networking. Connects and actively interacts with Medical Device Industry forums. Sells and makes recommendations to prospects and clients on the various solutions the company offers to solve their business issues. Generates proposals in compliance with Notified /Accreditation Body requirements and/or product sector requirements. Maximizes all opportunities within the process of closing a sale resulting in the taking of market share from competitors. Maintains accurate records of all sales and prospecting activities including sales calls, presentations, closed sales, and follow-up. Gathers and submits detailed business information for pricing. Creates and conducts effective proposal presentations and RFP responses that identify a prospects business challenges. Participates in and contributes to the development of educational programs offered to clients. Maintains effective working team relationships with all support departments. Assists in the implementation of company marketing plans. Communicates and effectively interacts with Global offices for related cost proposal approvals. At all times, complies with DNV Code of Integrity and Professional Conduct. Adheres to internal standards, policies, and procedures. Performs other duties as assigned. Degree in Marketing, Sciences, Biomedical Engineering, or related discipline. Medical Device Certification Business experience preferred. About 8 years of experience with a Medical Devices manufacturer and / or Notified Body including about 2 years in Sales desirable. Good Communicator & writing skills. Social media selling exposure. Well-read and updated on the Medical Device Sector happenings. Experience with ISO 13485, MDSAP, MDD, MDR, IVDR certifications. Experience in the Certification industry would be mandatory.

The role will be responsible to adding value from a global tax and compliance point of view with respect to International Tax, BEPS, POEM, MDR. This is an individual contributor who helps in positioning Amicorps products and services in alignment with the core business requirement. The role holder is responsible for analyzing the client entity structure as per the latest tax related regulations, including tax treaties, Economic Substance Requirements (ESR), anti-abuse rules, POEM, CFC, BEPS, Transfer Pricing Documentation; and should be able to analyze arrangements under the Mandatory Disclosure Rules (MDR, DAC6) in the European Union. - Analyze tax legislations / regulations/ guidance to derive requirements independently. - Act as the Point of Contact for multiple jurisdictions for any escalations/queries on related to tax treaties, economic substance requirements, anti-abuse rules, CFC, BEPS, Transfer Pricing Documentation. - Support teams in local offices with analysis and reporting of Mandatory Disclosure Rules (MDR, DAC6) in the European Union. - Assist the Tax Team with the operational tasks as required by the changing dynamics of various jurisdictions, globally like BEPS, POEM, changing tax treaties under the MLI, etc. - Be updated with local and global latest tax and compliance laws aimed towards tax transparent economies. - Understand the Global taxation rules applicable to U.S. Persons and non-U.S. Persons - Work in cooperation with Reporting and Global Manager to arrive at a commercially viable solution for tax and compliance needs - Actively support Reporting Manager in creating manuals, policy documents, training materials, tool-kits, etc. - Drive process excellence, automation, efficiency initiatives and Ensure SLAs & TAT (deliverables) are met.

Greetings From You & I Consulting ! You & I Consulting has always been in the spotlight for getting placed in 64+ MNC's PAN India. *Hurry Do Not Miss This Opportunity To Work For Global Giant MNC. We are hiring for the below locations under Medical Data Reviewer !! *Open Locations :- * Mumbai/ Pune/ Bangalore *Mode Of Interview - Virtual *Mode Of Work :- Work From Office * CTC Upto - Best In Industry *Call Now our HR Specialist:- @ puja - 8250242229 (call or whts app) PFB Job Insights for Medical Data Reviewer Role!! Responsibilities:- Review subject/ patient level data for accuracy, to identify any anomalies, trends in patient reported data Review and provide inputs ion design of eCRF • Review investigation product dosing Review all reported Adverse Events (AEs), Concomitant Medication and medical Ensure that any out of range data/ anomaly is verified Review all laboratory data on study subjects Review data in the form of visualizations and identify potential issues of concern Training new team members * * *Call Now our HR Specialist:- @ puja - 8250242229 (call or whts app) *Note:- *Though We Try and Answer The Calls Immediately, but Due to Heavy Call Flow The Below Numbers Might Be Busy At Times. In case you find the number busy, please whatsapp your details to us in the below format: - Name- Mobile number - Mail - Qualification - Total work experience - Current Organization- Location - Last CTC Expected CTC:- *Interested candidates can even refer their friends or relatives provided the criteria *FOR interview Call Now our HR Specialist:- @ puja - 8250242229 (call or whts app)

About Us We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence. As a trusted voice for many of the world’s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations. About SCPA We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers. About The Role We have a opportunity for a Medical Device Assessor/ Auditor to join our India Team. The successful candidate will be responsible for, planning and conducting audits/ assessments, in accordance with ISO 13485, EU MDR, and MDSAP standards and related (eg IMDR). Key Accountabilities Technical Compliances, Accreditation Requirements and collaborating with a Team of Auditors/ Assessors. Conduct audits (either desk-based or on client’s sites) in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships.Conduct Technical File reviews specific for products being authorized.Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business.Complete specific projects in relation to medical device procedures, processes, systems and documentation. If required, undertake reviews of packs and make certification decisions within target timescales and in line with DNV policies and accreditation/approval requirements.Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards. To be considered for this role, you’ll require about 10 years of professional experience in relevant field of healthcare products or related activities e.g.: work in medical devices industry such as research and development, manufacturing, quality management, regulatory affairs: work in health services, universities, foundations or other institutions carrying out inspections, audits, clinical evaluations, experimental and/or clinical research, including notified bodies.work in the application of device technology and its use in health care services and with patients.testing devices for compliance with the relevant national or international standards.conducting performance testing, evaluation studies or clinical trials of devices.5 + years relevant professional experience in quality management is essential. In addition to the above you’ll also need to demonstrate the following. An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques Good knowledge of ISO 13485, MDD 93/42/EEC/ Indian Medical Device Regulations and their applicationKnowledge of MDR 2017/745, MDSAP, IMDRWork experience in positions with significant QA, Regulatory or management systems responsibilityExperience with Harmonized medical device standards and for active & non active devices.Experience with Risk Management EN ISO 14971Experience auditing against recognized standards Experience of working under own initiative and in planning and prioritizing workloads Solid knowledge of non-active devicesSolid knowledge of sterilization processes The Following Attributes Are Essential Work actively with a Team of Assessors/ Auditors. Experience of reviewing audit packsReview of technical documentationRegistered IRCA lead auditor, or equivalent registration under other recognized body What we offer Flexible work arrangements for better work-life balanceGenerous Paid Leaves (Annual, Sick, Compassionate, Local Public, Marriage, Maternity, Paternity, Medical leave)Medical benefits ( Insurance and Annual Health Check-up)Pension and Insurance Policies (Group Term Life Insurance, Group Personal Accident Insurance, Travel Insurance)Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme)Additional Benefits (Long Service Awards, Mobile Phone Reimbursement)Company bonus/Profit share. *Benefits may vary based on position, tenure/contract/grade level* DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity. About You University or technical college degree or equivalent qualification in relevant sciences such as: Medicine, Pharmacy, Chemistry, Biochemistry, Biology, Microbiology, Biotechnology, Health Technology, Toxicology, Physics, Biophysics, Material Science Biomedical Engineering, Computer & Software Technology, Engineering, Nursing, Quality Management.Qualified MDR Assessor from a reputed EU Notified Body, desirable. Experience with scientific literature searches or peer review in the medical context.Fluent in written and spoken English.Experience working with Various Digital Tools.Excellent organizational and professional communication skills.

About Us We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence. As a trusted voice for many of the world’s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations. About SCPA We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers. About The Role We have a opportunity for a Medical Device Assessor/ Auditor to join our India Team. The successful candidate will be responsible for, planning and conducting audits/ assessments, in accordance with ISO 13485, EU MDR, and MDSAP standards and related (eg IMDR). Key Accountabilities Technical Compliances, Accreditation Requirements and collaborating with a Team of Auditors/ Assessors. Conduct audits (either desk-based or on client’s sites) in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships.Conduct Technical File reviews specific for products being authorized.Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business.Complete specific projects in relation to medical device procedures, processes, systems and documentation. If required, undertake reviews of packs and make certification decisions within target timescales and in line with DNV policies and accreditation/approval requirements.Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards. To be considered for this role, you’ll require about 10 years of professional experience in relevant field of healthcare products or related activities e.g.: work in medical devices industry such as research and development, manufacturing, quality management, regulatory affairs: work in health services, universities, foundations or other institutions carrying out inspections, audits, clinical evaluations, experimental and/or clinical research, including notified bodies.work in the application of device technology and its use in health care services and with patients.testing devices for compliance with the relevant national or international standards.conducting performance testing, evaluation studies or clinical trials of devices.5 + years relevant professional experience in quality management is essential. In addition to the above you’ll also need to demonstrate the following. An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques Good knowledge of ISO 13485, MDD 93/42/EEC/ Indian Medical Device Regulations and their applicationKnowledge of MDR 2017/745, MDSAP, IMDRWork experience in positions with significant QA, Regulatory or management systems responsibilityExperience with Harmonized medical device standards and for active & non active devices.Experience with Risk Management EN ISO 14971Experience auditing against recognized standards Experience of working under own initiative and in planning and prioritizing workloads Solid knowledge of non-active devicesSolid knowledge of sterilization processes The Following Attributes Are Essential Work actively with a Team of Assessors/ Auditors. Experience of reviewing audit packsReview of technical documentationRegistered IRCA lead auditor, or equivalent registration under other recognized body What we offer Flexible work arrangements for better work-life balanceGenerous Paid Leaves (Annual, Sick, Compassionate, Local Public, Marriage, Maternity, Paternity, Medical leave)Medical benefits ( Insurance and Annual Health Check-up)Pension and Insurance Policies (Group Term Life Insurance, Group Personal Accident Insurance, Travel Insurance)Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme)Additional Benefits (Long Service Awards, Mobile Phone Reimbursement)Company bonus/Profit share. *Benefits may vary based on position, tenure/contract/grade level* DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity. About You University or technical college degree or equivalent qualification in relevant sciences such as: Medicine, Pharmacy, Chemistry, Biochemistry, Biology, Microbiology, Biotechnology, Health Technology, Toxicology, Physics, Biophysics, Material Science Biomedical Engineering, Computer & Software Technology, Engineering, Nursing, Quality Management.Qualified MDR Assessor from a reputed EU Notified Body, desirable. Experience with scientific literature searches or peer review in the medical context.Fluent in written and spoken English.Experience working with Various Digital Tools.Excellent organizational and professional communication skills.

Job Description Job Overview: Perform conceptual, FEED, Studies, and detailed analyses and design as per design basis, project specifications, design codes and standards. Direct Engineering team as a Lead Engineer on small projects. Apply knowledge and skills to a wide range of standard and nonstandard situations. Prepare clear and accurate detailed design calculations and analyses including design reports and procedures. Manage own time to meet agreed deadlines and budgets and develop plans for short-term work activities in own area. Clearly communicate and explain complex issues and work to establish understanding. Responsibilities Key Tasks and Responsibilities: Be fully familiar with the project scope of work, specifications, schedule and all inter-discipline requirements; including identifying concerns as early as practicable and taking appropriate initiatives to address the issuesIdentify changes to scope and promptly raise change notifications, including providing any necessary supporting documentation and estimates. Provide similar support for Variation OrdersInterface with other departments to obtain input for Discipline designs and drawingsMaintain close co-ordination with other engineering disciplines, Planning, Fabrication, Marine, and Project Management Team, as requiredAssist in preparation of estimates for bid proposals, including technical query reviews, execution statements and manhour estimatesPrepare Discipline engineering design basis, philosophies, and technical specifications, as requiredParticipate in finalizing deliverables lists and deliverables, ensuring compliance with specifications and functional integrityAttend project review meetings, vendor meetings, engineering meetings and offshore site surveys, as requiredProvide technical direction and review of Designers producing products related to Fire Protection & Safety EngineeringPrepare and review design reports and proceduresAssist in providing necessary design inputs to other disciplines to enable them in proceeding with their deliverablesAssist procurement personnel in procuring Discipline equipment, materials and services; ensuring that work produced complies with Customer objectives and procedures. Procurement assistance includes preparing and reviewing requisitions, evaluating technical quotations and preparing queries, compiling bid tabulations and recommendations, preparing purchase requisitions, and coordinating with Procurement to expedite vendor documents, as directed by Discipline Lead EngineerAssist in updating weight report based on receipt of vendor informationCheck engineering performed by others within Discipline (interdiscipline checks)Review vendor and subcontractor submittals, checking for compliance with project specifications and providing comments as necessaryPerform design verification through single-discipline check/ inter-discipline check (IDC)Keep the Lead Engineer/ PEM apprised of all activities and concerns, technical, budgetary and manpower relatedAssist in providing inputs for actual, planning and forecasting progress reports including associated productivityCheck final subcontractor and vendor data manuals to ensure that all requested data has been received and approvedParticipate in internal, Customer and third party technical audits on engineering deliverables and vendor documentsAssist Lead Engineer with responses to Customer and other agencies (such as certifying authorities, auditors, third parties, etc.) on their review and approvalCapture lessons learned and enter into MDR's Lessons Learned systemGuide less experienced engineers on MDR and Discipline procedures, standards, worksheets, design calculations, software, requisitions, technical bid evaluations, technical queries, etc.Prepare design HSE & fire protection philosophiesPrepare safety study scope of work specifications, requisitions, TBE and purchase requisitionsPrepare/ review safety equipment listsPrepare/ review firefighting equipment specifications and data sheetsPrepare/ review life saving and personnel safety equipment specifications and data sheetsPrepare/ review safety sign specifications and data sheetsPrepare / review firewater demand and hydraulic calculation reports using PIPENET or equivalent softwarePrepare, review, and provide inputs to P&ID markups for Firewater ring main system and Deluge system including providing details of interconnection with hose reels, monitors, hydrants and deluge valves / nozzlesPrepare/ review escape route and safety equipment layoutsPrepare / review safety sign layoutsReview third party safety study reports that are in compliance with project specificationsParticipate, assist Lead Engineer coordinate safety workshops (such as HAZID/HAZOP) and provide inputs to safety study consultantsAssist Lead Engineer coordinate safety study close outs and prepare safety study close out reports. Review FP&S and relevant other disciplines' vendor dataPrepare / review technical notes on PFP rating requirements for the project based on Safety Study recommendationsProvide inputs for FP&S layouts, fire and gas detector layouts and fire and gas cause and effects matricesPrepare/ review safety study safety action monitoring system (SEAMS) and SEAMS registersProvide and review safety inputs to operations manuals Qualifications Essential Qualifications and Education: 8-15 yrs in oil and gas with major contractor or consultant predominantly performing detail design Bachelor Degree or Master Degree in EngineeringStrong working knowledge of many design techniques and analysis methods, and detailed knowledge of the content and application of standards codes and guidelines as applicable About Us Our ingenuity fuels daily life. Together, we’ve forged some of the most trusted partnerships across the energy value chain to make what was once just an idea a reality: laying subsea infrastructure thousands of feet below sea level, installing platforms hundreds of miles from shore, using our expertise to design and build offshore wind infrastructure, and reshaping the onshore landscape to deliver the energy products the world needs safely and sustainably. For more than 100 years, we've been making the impossible possible. Today, we're driving the energy transition with more than 30,000 of the brightest minds across 54 countries.