Employment

EMPLOYMENT

pOSITION TITILE:  Regulatory affairs specialist II

duties

Support development & creation of regulatory documents in accordance with MDD, MDR, FDA 21 CFR Part 820, MDSAP for medical device manufacturing; conduct regulatory literature reviews for medical devices; develop & write procedures and provide written responses to audit findings; prepare usability files, risk management procedures, design control activities, complaint handling procedures, corrective & preventative action procedures, post market surveillance activities, management meetings; lead quality audits; perform system-wide interviews to determine best course of action for procedure development.

responsibilities

1. Prepare submissions (g., 510(k)s, Investigational Device Exemption (IDE), etc) for US regulatory agencies.
2. Prepare submissions (Technical Documentation File) for regulatory agencies.
3. Provide responses to all regulatory agencies regarding product information or issues.
4. Review all regulatory agency submission materials to ensure accuracy, timeliness, comprehensiveness, and compliance with regulatory standard.
5. Develop regulatory strategies and implementation plans for the preparation and submission of new products.
6. Manage activities such as audits, regulatory agency inspections and product recalls.
7. Formulate and implement regulatory affairs policies and procedures to ensure that compliance is maintained.
8. Develop Clinical Evaluation Reports.
9. Develop Post Market Surveillance Reports.
10. Develop Risk Management Files.
11. Maintain current knowledge of relevant regulations.
12. Review materials such as marketing literature, instructions for use and labeling to ensure compliance is maintained.
13. Communicate regulatory information to multiple departments and guide them towards implementation.
14. Direct documentation efforts to ensure compliance with domestic and international regulations and standards.
15. Participate in complaint investigation and prepare documents as necessary.
16. Represent organization before domestic and international regulatory agencies on decisions regarding company matters.
17. Review clinical trial protocols for regulatory submissions.
18. Develop employee regulatory training.
19. Conduct product literature reviews.

credentials

Master of Science in Regulatory Affairs for Drugs, Biologics & Medical Devices or related field

rate of pay

$85,000.00 per year