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Regulatory Affair Lead
Quest Global Technologies
posted 2mon ago
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Flexible timing
Key skills for the job
Job Description
- Regulatory Compliance: Ensure that company products and processes comply with relevant regulations, such as FDA (21 CFR Part 820), ISO 13485, EU MDR, IEC 62304 and other global standards.
- Submission Preparation: Prepare and submit regulatory submissions, including 510(k) notifications, PMA applications, IDEs, and post-market surveillance reports.
- Analyze the regulatory needs and customer requirements on active medical devices on electrical, mechanical and software components.
- Responsible for owning & leading entire Medical Device for remediation according to customer requirement.
- Execute the remediation project by guiding the remediation engineers.
- Review of the artifacts modified or prepared for remediation projects.
- Prepare technical documentation dossiers for regulatory submissions, including design controls, risk management plans, and performance testing data.
- Product Development: Collaborate with cross-functional teams to develop new products, ensuring regulatory compliance throughout the product lifecycle.
- Audits and Inspections: Coordinate internal audits and prepare for FDA inspections by ensuring compliance with regulations and maintaining accurate records.
- Manage the regulatory submission process for new and existing medical devices, working closely with notified bodies and regulatory agencies.
- Track regulatory timelines and milestones, ensuring timely submissions and approvals.
Work Experience
- Bachelor / master degree in a related field, such as biomedical engineering, Mechanical Engineering, Electrical and Electronics Engineering or related life science.
- 7-12 years of experience in medical device industry
- Minimum 8 years of experience in medical device regulatory affairs, preferably with experience in the active medical device (Entire life cycle).
- Hands on experience in DHF Gap Assessment and Remediation for FDA 21 CFR Part 820, EU MDR.
- Experience working in Class II or Class III products preferred.
- High exposure to prepare/correlate regulatory compliance of active medical devices in full lifecycle.
- Able to understand the regulatory needs and customer requirements on active medical devices on electrical, mechanical and software components.
- Strong leadership and mentoring skills, with the ability to guide junior team members and lead cross-functional projects.
- Ability to interpret complex regulations and guidelines, applying that knowledge to practical scenarios.
- Familiarity with computerized systems, such as electronic submission systems (e.g., FDAs eSubmitter).
Employment Type: Full Time, Permanent
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What people at Quest Global Technologies are saying
Rating based on 1 Lead
review
Anonymous · Quality Assurance and Testing
in Bangalore / Bengaluru
Likes
Some of the idu they are doing good following good culture.
Dislikes
The idus I am working so far it's average, most of the team members are not at all fit for their position including managers.
Read 1 reviewWhat Quest Global Technologies employees are saying about work life
based on 150 employees
Flexible timing
Monday to Friday
No travel
Day Shift
Quest Global Technologies Benefits
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