9 Eu Regulations Jobs

The Know Your Client Key Operating Standards (KYC KOS) team sets, maintains, and governs the minimum operational standards for key processes utilized by KYC Ops in Bangalore, India. As an AVP in this team, you will play a crucial role in supporting key stakeholders to assess and understand KYC and Sanctions Policy requirements. Your responsibilities will include translating these requirements into minimum standards for implementation by KYC Ops, addressing queries, supporting policy-driven change initiatives, and producing clear guidance documents. Your contributions will ensure that client due diligence performed by KYC Ops complies with KYC and Sanctions Policy as well as relevant laws. You will collaborate with AFC and Sanctions Policy teams to understand policy changes and translate them into operational language for implementation by KYC Ops. Providing subject matter expertise on Policy/KOS topics, offering real-time advisory on KYC and Sanctions Policy, and ensuring proper documentation of KOS requirements will be key aspects of your role. Proficiency in English language with strong communication skills, working knowledge of KYC and Sanctions Policies, and experience in supporting Policy change management will be essential for success in this role. Additionally, a willingness to embrace new technology and innovative solutions will be beneficial. Benefits you can enjoy as part of the flexible scheme include a best-in-class leave policy, gender-neutral parental leaves, sponsorship for industry-relevant certifications and education, employee assistance program, comprehensive hospitalization insurance, accident and term life insurance, and complementary health screening for individuals aged 35 years and above. Training, coaching, and a culture of continuous learning are provided to support your career progression within the team. Deutsche Bank Group strives for a culture of empowerment, responsibility, commercial thinking, initiative, and collaboration. They promote a positive, fair, and inclusive work environment where all individuals are welcomed and celebrated. For further information about the company, please visit their website at https://www.db.com/company/company.htm.,

As a Senior Packaging Engineer, you will be responsible for designing, developing, and testing packaging solutions for medical devices. Your primary goal will be to ensure that the designs meet legal, quality, and cost requirements while protecting against environmental factors like moisture, chemicals, temperature, and tampering. Additionally, you will oversee the packaging design process from validation to manufacturing transfer, working collaboratively across different functions. Your key responsibilities will include designing both sterile and non-sterile medical device packaging in compliance with industry standards such as ASTM, ISTA, IEC, UL, FDA, and EU regulations. You will need to engage with OEMs and cross-functional teams to ensure that packaging solutions meet functional and regulatory requirements. Leading the design, material qualification, verification, validation, and implementation of packaging solutions will also be part of your role. Furthermore, you will manage engineering change control, documentation, and technical reporting related to packaging specifications and testing. Developing and revising artwork and labeling for product packaging using CAD and artwork tools will be essential tasks. You will utilize CAD software such as Creo, SolidWorks, and Adobe Illustrator/Corel Draw for packaging design purposes. Project management will be a crucial aspect of your job as you will be responsible for overseeing multiple packaging projects to ensure timely and high-quality delivery. Supporting prototype line development and manufacturing transfers with plant facilities will also fall under your purview. It will be imperative to maintain Good Manufacturing Practice (GMP) and regulatory compliance in all packaging solutions developed. To be successful in this role, you should possess a Bachelor's degree in Packaging Engineering or a related field with 8-12 years of experience, or a Master's degree with 4+ years of experience. Hands-on experience in packaging material qualification, testing, CAD software (Creo, SolidWorks), and Product Lifecycle Management (PLM) tools like Windchill and Agile will be necessary. Proficiency in medical device standards such as FDA, EU MDR, ASTM, ISO, and IEC is also required. Strong communication and collaboration skills will be essential as you engage with various stakeholders. You should also demonstrate the ability to manage multiple projects simultaneously, showcasing strong organizational and project management skills. Preferred qualifications for this role include GD&T certification, experience with medical device product/site transfers, and familiarity with packaging-related production methods and artwork/labeling tools.,

Join us as a Senior Auditor specializing in Model Risk, where you will contribute to independent engagement assurance by undertaking allocated tasks within the engagement life cycle. Your role will involve providing quality, efficient, and effective assurance while influencing business managers to enhance control measures. This fast-paced and varied position will allow you to expand your network within the bank by collaborating with a diverse group of stakeholders and senior employees. This opportunity is available at the associate vice president level. As a Senior Auditor in this role, your responsibilities will include assessing risks and controls, conducting testing, and contributing to continuous monitoring by analyzing management information or reviewing risk data. You will engage with business stakeholders throughout engagements to ensure a comprehensive understanding of business risks and facilitate open discussions on key risks. Additionally, you will participate in discussions to influence the prudent management of risk, lead small engagements, and produce engagement reports that effectively guide business managers in managing risks within their risk appetite. Your duties will also involve delivering elements of regular or complex audit engagements, contributing to assurance planning, conducting effective process mapping, leveraging cutting-edge audit methodology and tools, coaching auditors, and sharing knowledge across the function related to specific engagements. To excel in this role, you should have previous experience in a model risk environment, along with a background in audit, assurance, or risk management. Strong analytical and problem-solving skills are essential, as well as the ability to assess and prioritize data effectively. You should possess a solid understanding of good risk management principles, stakeholder management skills, experience in using artificial intelligence (AI), machine learning (ML), and GenAI technologies for data analysis, as well as credit model development/validation expertise covering IRB and/or IFRS9 models. Knowledge and comprehension of relevant prudential regulatory authority (PRA) and European Union (EU) regulations pertaining to credit models are also required. Previous internal audit experience involving credit models (IRB and/or IFRS9), including leading audits or making significant contributions to complex and high-profile audit engagements, will be beneficial.,

The PV Specialist is responsible to have oversight and management of SDEAs/PVAs for Business relationships in all regions. This includes coordination with various stakeholders, business relationship assessment, SDEAs/PVAs drafting, review & revision for Dr Reddy's business relationships ensuring to meet the standard process and applicable regulatory requirements. Responsibilities: To coordinate with various stakeholders involved in Business relationship of all regions to ensure: All main agreements are assessed for PV obligations to ensure either a PV clause or a separate SDEA/PVA is required and placed Existing SDEAs/PVAs are up to date with respect to the current templates with standard procedures and aligned with current legislation Ensuring that all key PV stakeholders are involved to support in drafting, review, approval and sign off of PVAs with necessary PV obligations based on Business terms, regulatory requirements and standard procedures. Lead the negotiation process with Business partner for all PVAs with support from Global PV Head, Head of PV Operations and Regional PV Heads as needed. Ensure all executed PVAs and its Main agreements are tracked within Global Comprehensive tracker and filed within dedicated share folder. PVAs Periodic revision: manage the process in set periodic cycle for review and update of existing PVAs to ensure all provisions are up to date with regulatory requirements and standard procedures. Periodically reviewing existing PVA templates to align with standard functional process and to design standard templates with the support and approval of Global PV Head and Head of PV Operations. Maintain comprehensive contracts Master list and Global PVA Exchange Matrix for all active PVAs and main contracts with PV clause to support the PV functional process implementation. Devise and maintain a process for ensuring the implementation of PVAs post- signing. Monitor ongoing compliance with terms and conditions of PVA and provide updates during internal compliance meetings. Ensure major non-compliance is escalated. Provide list of agreements to support generation of the PSMF when required Support PV due diligence activities for new product acquisitions/divestments as needed. Act as SME for PVA management during audit and regulatory authority inspections Relationship Management Build relationship with key stakeholders Regional PV Leads, Business Units and legal as applicable. Define practices under the supervision and support of Global PV Head and Head of PV Operations to implement the same. Process Improvement / Standardization Ensure PVA templates keep pace with changes in legislation Identify areas of process improvement and propose recommendations Support process automation for PVA management, including establishing database reporting rules for distribution of ICSRs to partners Resolve issues related to PVAs with teams. Qualifications Desired Skills & Competencies Knowledge of global regulations including FDA, EU & emerging market guidelines. Understanding of PV operations to ensure appropriate negotiation of terms in all PVAs Demonstrate understanding of commercial agreements with a view to matching the required PV strategy to the commercial relationship Previous experience in PVA management Excellent teamwork and interpersonal skills Excellent time management and organisational skills

Our Senior Regulatory Affairs Specialist position is primarily focused on supporting regulatory sustaining activities within the SM organization, including providing support for change control activities and continued compliance with postmarket MDR and IVDR regulatory requirements. The ideal candidate will be energetic, possess strong regulatory technical knowledge (particularly in the area of change control), have experience supporting MDR and IVDR requirements, and perform well independently and as part of a team. Be part of something bigger! BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues. In BD Specimen Management (SM), we develop some of the most widely used products in the field of specimen collection including acquisition of the sample, collection into an appropriate container, and also emerging point-of-care applications. Our team has the unique opportunity to be involved with both medical devices and in vitro diagnostics, allowing you to broaden your expertise and grow in your career. Our Senior Regulatory Affairs Specialist position is primarily focused on supporting regulatory sustaining activities within the SM organization, including providing support for change control activities and continued compliance with postmarket MDR and IVDR regulatory requirements. The ideal candidate will be energetic, possess strong regulatory technical knowledge (particularly in the area of change control), have experience supporting MDR and IVDR requirements, and perform well independently and as part of a team. Our people make all the difference in our success. Join us in our mission to advance the world of health. Support the Regulatory Affairs function on Product Lifecycle Management (PLM)/Sustaining project teams and liaise with Regulatory Affairs subject matter experts (SMEs) to fulfill US FDA and EU CE requirements. Assist in compiling, drafting and submitting the required submission documents to support 510(k) and/or CE Technical File Documentation, (eg STeD ) to obtain clearances and/or approvals to established timelines. Assist and manage Notification of Change (NOC)/International Regulatory Affairs assessments of PLM/Sustaining activities to ensure regional/country requirements of US, EU and Rest of World (ROW) are captured in Regulatory strategy development. Develop regulatory strategies for Change Controls (CC) and establish Regulatory Requirements. Monitor completion of all CC task requirements recorded in the PEGA CC system and verify completion of requirements before Engineering Change Release ECRO release. Monitor and assess the impact of existing, modified and new standards pertaining to BD products for the US and EU markets and maintenance of related regulatory documentation. Support regulatory efforts to maintain and /or simplify technical documentation maintenance, labeling changes/remediations projects and UDI assessments. Review and approve labeling and promotional material for compliance to FDA and EU regulations. Support completion of EU Substantial Change Notifications and Substantial Change Applications for approval. Prepare responses to notified body inquiries. Prepare EU CE re-certification applications following notified body templates with supporting evidence from cross functional teams. Provide training or deliver presentations to cross-functional groups across TCI and SM on salient regulatory topics. Recognize potential compliance problems areas or associate ambiguity and make recommendations to resolve. Work independently and carries out the above tasks with minimal supervision. Education and Experience: B.S. degree in a scientific, health sciences or technical discipline (e.g., engineering, bioengineering, biology, chemistry). Minimum 5 years regulatory experience and working knowledge in regulated medical device or in vitro diagnostic device companies or an equivalence combination of experience with an advanced degree. Experience in preparing, approving and maintaining Technical Documentation and other submissions compliant with US, EU and global regulations. Experience in supporting product development projects for product and process changes. Demonstrated ability to participate on cross-functional team to consistently to meet regulatory requirements and project timelines. Proficient in using Microsoft Word, Excel, PowerPoint, and Project. Strong communication (written, oral) and project management skills. Able to handle multiple competing tasks with great attention to detail. Able to work independently to achieve objectives on or before schedule. Demonstrated cross-functional collaboration and teamwork skills including influencing without authority. Comprehensive knowledge of medical device regulations and standards. Current knowledge of European quality system standards, and requirements under EU MDR and IVDR preferred. Ability to navigate ambiguous regulatory requirements and standards interpretation.,

The role you are applying for will involve coordinating with Group CISO & the Asia Pacific Region (APR) Risk Management team to implement central directives regarding cybersecurity governance, conducting analysis, and organizing committees within APR. This position will report directly to the Regional Head of Risk Management, Asia Pacific Region (APR). The ideal candidate for this role should have experience working as a Chief Information Security Officer (CISO) with a background in Cyber Security, Cyber Risk Management, and Risk Management. You will be responsible for managing the APR region (Asia Pacific/Europe) and should have prior experience working with APR countries or other Asian countries, primarily Europe. It is essential to have expertise in developing and executing security strategies. Candidates with a history of frequent job changes (e.g., almost every year) will not be considered. Knowledge of EU regulations, such as DORA, is advantageous. Certifications such as CISSP, CISM, or CISA are required for this position. Your main responsibilities will include adapting Group documents to enhance local cyber resilience, organizing quarterly regional ISS Committees, cascading risk mapping to the local level, supporting the assessment of local third parties" security, advising on local/regional IT and Cyber Projects, and overseeing cybersecurity regulations in Asia Pacific. You will also be involved in conducting Cyber Risk assessments at a regional level and other risk management activities as needed. Candidates should hold a bachelor's degree in information technology, computer science, or a related field. Professional qualifications such as CISSP, CISM, or CISA are necessary. A minimum of 10 years of experience in IT management/cybersecurity governance or related fields, preferably in financial institutions, is required. You should have a strong understanding of security principles, standards, and technologies, including access control, network security, identity management, and cyber incident management. The candidate should possess strong communication and interpersonal skills to collaborate effectively with stakeholders at all levels. Being well-organized, detail-oriented, a good team player, and capable of establishing and maintaining effective working relationships with internal stakeholders are essential attributes for this role. Additionally, you should be able to work independently and demonstrate strong self-motivation.,

The Know Your Client Key Operating Standards (KYC KOS), Associate position in Bangalore, India at Deutsche Bank involves setting, maintaining, and governing the minimum operational standards for key processes utilized by KYC Ops. The KYC Team, managed from London and Frankfurt, with a global presence in Singapore, India, Birmingham, and Jacksonville, ensures client due diligence compliance with KYC and Sanctions Policy and relevant laws. In this role, you will support key stakeholders in understanding KYC and Sanctions Policy requirements and translating them into minimum standards for implementation by KYC Ops. You will address queries, assist in policy-driven change initiatives, and create clear guidance documents. Collaboration with AFC and Sanctions Policy teams, providing real-time advisory, and ensuring proper documentation of KOS requirements are key responsibilities. The position requires a working knowledge of KYC and Sanctions Policies, especially German and EU Regulations, along with experience in supporting policy change management. Proficiency in English language, willingness to embrace new technology solutions, and strong communication skills are essential. The role also offers various benefits under a flexible scheme, including leave policy, parental leaves, childcare assistance, sponsorship for certifications, and more. As part of Deutsche Bank, you will receive training and development opportunities, coaching from experts, and a culture of continuous learning. The company values responsible actions, commercial thinking, initiative, and collaborative work. Applications from all individuals are welcomed to promote a positive and inclusive work environment within the Deutsche Bank Group.,

As a qualified candidate for this role, you should possess a Graduate or Post Graduate degree in Food Science, Technology, Microbiology, Chemical, Process Engineering, or a related field. Your academic background should be coupled with a minimum of 5 years of experience at the Assistant Manager level in Research & Development (R&D), particularly in the areas of Frozen Foods, Ready to Eat, Snacks, and Baking. An ideal candidate would also have a strong understanding and technical know-how of the Frozen Food industry. You should have experience and familiarity with multi-product technology and multi-location/cultural settings, encompassing Production, Quality, and other relevant areas. Your technical and functional skills should include a comprehensive knowledge of ingredients, processes, and technologies involved in the production of Frozen Foods, Ready to Eat items, Snacks, and Baking products. Additionally, a good understanding of FDA, EU, and FSSAI regulations, as well as proficiency in SAP, would be advantageous in this role. Furthermore, you should exhibit a solid commercial and operational understanding, including financial acumen, marketing strategies, and consumer insights. This role requires full-time commitment on a permanent basis, with a work schedule that may involve rotational shifts. An added benefit includes a yearly bonus. The work location for this position is on-site.,

As a member of our Medical Device team, you will not only manage a small team of globally based Product Assessors but also dive deep into the exciting world of Active Medical Devices. Your responsibilities will include: Supporting and guiding your team of talented Product Assessors Conducting thorough technical documentation reviews and ensuring compliance with EU regulations and standards. Collaborating with cross-functional teams to increase efficiency and quality Monitoring the teams technical competence, KPIs, and wellbeing and providing feedback and support when there are concerns. Conduct recruitment, including reviewing CVs and undertaking interviews and supporting with onboarding of new starters Develop training and present the training to others in SGS or externally as deemed necessary. Assist with technical queries and those related to sales within the Active Medical Devices field. Ensure that the highest level of service is provided throughout the SGS network offering medical devices certification and stakeholders through efficient service delivery.