Job Description :
Job Description:



SUMMARY: The Regulatory Affairs Specialist is responsible for obtaining US and OUS product clearances as well as maintaining Technical Files and Establishment Licenses. Also participants in worldwide Field Actions. In addition, the Regulatory Affairs Specialist communicates significant design changes outwardly to Distribution Partners, while also communicating changes in the evolving regulatory landscape inwardly to product development team.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

1. Responsible for supporting Regulatory Affairs domestically as well as European registrations and submissions, technical file maintenance and recall coordination.

2. Stay up-to-date and follow all Quality System procedures related to this job, which can affect the quality of products or services provided to our customers.

3. Manage response for regulatory requests from customers, distributors or regulatory agencies.

4. Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies.

5. Maintain company registrations and device listings in the US, Canada and the EU.

6. Support/maintenance of technical files, MDD certifications and declarations of conformity in support of EU product registrations/CE mark.

7. Recall coordinator for product recalls.

8. Support and report departmental metrics and reports to executive management.

9. Provides support and backup for other QA/RA functions.

10. Supports internal/external audits and regulatory inspections.

11. Perform other quality assurance and quality control functions as necessary, with appropriate training.

Travel Required: The employee is occasionally required to travel by car and/or airplane to other company facilities or other remote locations as required.

QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and/or Experience

12. Bachelor''s Degree (B.S from a four-year college or university in Engineering, Bio-Medical Engineering, Sciences or related field.

13. Minimum 6 years of Regulatory Affairs work experience in medical device (Class II and Class III

14. Strong knowledge and experience with 510(k) preparations and submissions required.

o Must have demonstrated experience with submissions in Canada and EU.

o Experience with international countries a plus.

15. Current knowledge of FDA and International quality system regulations required.

16. Specific experience following Device Design Controls and Risk Management Processes.

17. Experience with Electronic Medical Equipment preferred.
             

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