3208 Regulatory Affairs Jobs - Page 9

Project Manager- Business Consulting Risk - FSRM Our FSRM team is a fast-moving, high-growth area with huge potential. It offers variety, challenge, responsibility, and the opportunity to realize your leadership potential. Our Financial Services Risk Management (FSRM) practice focuses on risk management, regulatory, quantitative, and technology backgrounds. The breadth of experiences of FSRM professionals enables the practice to coordinate the delivery of a broad array of risk management services to capital market participants throughout the world in a well- integrated manner.

Job responsibilities: Having experience in concurrent Audit Conducted Comprehensive audit for banks To ensure accuracy, authenticity, and compliance with the procedure and guidelinesof banks are followed. Working on regulatory returns of bank Should be presentable and have good communication skills

Collect and review documents to ensure FGI has the appropriate documents required. Complete work permit and other immigration forms. Assist in the preparation of letters for case work. Collate cases for submission. Prepare submissions for client signature and upload to IRCC portal for adjudication. Update case management system throughout entire case lifecycle (milestones, emails, approvals, etc.). Communicate with client through balance of process for updates. Review and update client reports on a daily/weekly basis. Generate weekly client status and audit reports via case management system.

Job Responsibilities- Assisting in developing audit planning documentation addressing scope,auditobjective, budgeted hours, resource plan,and reporting date Complete assignedaudits, addressing allauditobjectives, conducting clientandstatus meetings as required, controlling, monitoring,and reporting onauditprogress, reviewing work papers,and ensuring work papers provide adequate support of conclusions while complying with internal standards for documentation. To monitor the assignment for improving the efficiency of the assignment, manageauditin relation to time and resource budget Will actively check that all findingsandissues are documentedandperform closedown procedures Gatheringandcompili...

: Execute audit strategy and plan of concurrent audits testing in accordancewith the Policies, Procedures, Legal, Statutory and Regulatory requirements, Internal Audit Standards, and leading best practices. Maintain and update concurrent audit procedures and checklists to ensure they remain current and updated keeping pace and aligned with changes in internal policies/guidelines as well as legal/statutory/regulatory changes and evolving industry best practices. Ensure timely and quality execution of concurrent audit reviews . Ensure timely completion of Concurrent audit plan with quality of audits, and meet with all concurrent audit documentation and reporting requirements as per Concurrent ...

We are seeking an experienced Consultant with deep expertise in CE Marking and Indian Standards (IS/BIS) to support Omnex clients in achieving product compliance and certification project implementation, client engagement, and training delivery.

What you will do: Interact with surgeon to collect VOC and analyze competitor systems to establish user needs. Utilize knowledge of surgical techniques to design & develop novel solutions addressing user and business needs for the Trauma Business. Fulfill key design control requirements including generating DIOVV, risk analysis, dFMECA and design reviews. Work with independent reviewers and quality assurance personnel to finalize and approve DCDs. Collaborate with Advanced Operations and vendors to DFM product designs and finalize drawings. Act as R&D representative for creation of DCPs and IGS. Conduct tolerance stack up analysis on developed design to verify product. Liaise with BML person...

Who we want: The Tools Administrator will assist in the ongoing adaptation and deployment of new tools such as JAMA Windchill/ DOORS. The administrator will work closely with functional leaders, organizational units, and subject matter experts to identify develop and deploy new business processes. This role is part administrator, part quality analyst and part trainer. The Administrator will be responsible for executing on the day-to-day configuration, support, maintenance and improvement of the tools, qualification of the tools and associated processes. The Administrator will manage the relationship with the software vendors and be responsible for documenting and updating internal processes ...

Develop and implement regulatory compliance programs to ensure adherence to industry standards.Conduct thorough analysis of regulatory requirements/ provide expert guidance on compliance matters.Collaborate with cross-functional teams to identify Required Candidate profile Strong knowledge of regulatory compliance principles, practices, and procedures.Excellent analytical, communication, and problem-solving skills.Ability to work effectively in a fast-paced environment

Job Responsibilities: Dossier preparation/review as per country specific guideline/CTD guideline Timely query response submission to Distributor/ MOH Review of documents for its correctness and compliance with respective regulatory guidelines (as per country requirement) Preparation, review & release of artworks & sales order as per country approval Variation documents preparation and filing as per country requirements Timely dispatch of tender documents to country/parties as per deadline Candidate profile Should be able to review & interpret the requirement as per country specific/ tender guideline/Query received from MOH Should be able to review various plant documents for dossier preparat...

Coordinate and prepare regulatory submissions, including applications, reports, and other documents.Ensure compliance with relevant laws, regulations, industry standards.Develop and maintain relationships with regulatory authorities Required Candidate profile Strong knowledge of regulatory submissions, compliance, and industry standards.Excellent communication and interpersonal skills.Ability to work independently and as part of a team.

Conduct thorough medical device safety assessments and evaluations.Develop and implement effective safety protocols and procedures.Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Required Candidate profile Strong knowledge of medical devices and their safety regulations.Excellent analytical and problem-solving skills.Ability to work effectively in a fast-paced environment.

Manage and oversee the daily operations of the airline passenger support service team.Develop and implement strategies to enhance customer satisfaction and efficiency.Coordinate with airlines, airports, other stakeholders to ensure seamless Required Candidate profile Proven experience in managing teams and leading projects in the airline industry.Strong knowledge of airline regulations and standards.Excellent communication, interpersonal, problem-solving skill

Coordinate regulatory submissions and ensure compliance with relevant laws and regulations.Prepare and review regulatory documents, including applications and reports.Collaborate with cross-functional teams to meet regulatory requirements. Required Candidate profile Strong knowledge of employment firms and recruitment services.Excellent communication and coordination skills.Ability to work effectively in a fast-paced environment.

Develop and implement regulatory compliance programs to ensure adherence to industry standards.Conduct thorough analysis of regulatory requirements and provide expert guidance on compliance matters. Required Candidate profile Strong knowledge of regulatory compliance principles, practices, and procedures.Excellent analytical, communication, and problem-solving skills.Ability to work effectively in a fast-paced environment

Conduct thorough medical device safety assessments and evaluations.Collaborate with cross-functional teams to identify and mitigate potential risks.Develop and implement effective safety protocols and procedures. Required Candidate profile Strong knowledge of medical devices and their safety regulations.Excellent analytical and problem-solving skills.Ability to work effectively in a team environment.

Publish regulatory submissions to relevant authorities, ensuring compliance with required standards and regulations.Coordinate with cross-functional teams to ensure timely submission of regulatory documents. Required Candidate profile Strong understanding of employment firms and recruitment services.Excellent publishing skills, with attention to detail and ability to meet deadlines.Ability to work independently

Develop and implement regulatory compliance programs to ensure adherence to industry standards.Conduct thorough analysis of regulatory requirements/ provide expert guidance on compliance matters.Collaborate with cross-functional teams to identify Required Candidate profile Strong understanding of regulatory compliance principles and practices.Excellent analytical, communication, and problem-solving skills.Ability to work effectively in a fast-paced environment

Coordinate and prepare regulatory submissions, including applications, reports, and other documents.Ensure compliance with relevant laws, regulations, and industry standards. Required Candidate profile Strong knowledge of regulatory submissions, compliance, and industry standards.Excellent communication and interpersonal skills.Ability to work independently and as part of a team.

Conduct thorough medical device safety assessments and evaluations.Develop and implement effective safety protocols and procedures.Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Required Candidate profile Strong knowledge of medical devices and their safety regulations.Excellent analytical and problem-solving skills.Ability to work effectively in a team environment.

8 years experiences for RA role in medical device and or pharmaceutical industry.Good understanding for regulations and policies issued by India, US FDA and EU, and ability to interpret international regulatory requirements. Required Candidate profile Desired Skills:RA role in medical device, US FDA and EU. Bachelor degree in Medical, Mechanical, Electric Life Science or other healthcare related majors.

Procurement Operations: Source and procure raw materials (APIs, excipients), packaging materials, and other pharma-related items. Evaluate purchase requisitions and coordinate with internal departments (production, QA/QC, R&D) to ensure timely procurement. Issue purchase orders (POs) and track their status until delivery and GRN. Vendor Management: Identify, evaluate, and develop new suppliers and maintain strong supplier relationships. Negotiate prices, payment terms, delivery schedules, and contracts. Monitor vendor performance based on quality, cost, delivery, and service. Inventory & Cost Control: Coordinate with the inventory team to maintain optimum stock levels. Analyze and control pr...

About The Role Job Title Responsible AI Associate Manager Project Role : Responsible AI Advisor Management Level: 8 Project Role Description : Develop strategies to ensure the ethical and responsible use of artificial intelligence (AI) technologies. Shape the strategic direction of guidelines, policies, and practices implementation to mitigate AI-related risks. Promote transparency, accountability, and align AI initiatives with the organizations values and legal requirements. Must have skills : Responsible AI Good to have skills : NA Summary :As a Responsible AI Advisor, you will develop strategies to ensure the ethical and responsible use of artificial intelligence technologies. Your typica...

About The Role Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to li...

Job Profile Quality Assurance, Quality Control, Clinical Research , Regulatory Affairs, Medical Record Summarization , Medical Claims , Medical Officer, Medical Billing , Pharmacist, ADL, ARD, FRD, CDM, Production, R&D , Lab Technician