MGR REG AFFAIRS

ESSENTIAL FUNCTIONS: 1. Track all new and existing product development for broad range of product categories.

2. Conduct meetings with Engineering and Marketing personnel to assess/assign critical elements for new product submissions to FDA and international authorities.

3. Develop and/or approve regulatory strategies.

4. Prioritize and assign tasks to RA Associates/Sr. RA Associates.

5. Prepare or review product registration dossiers, e.g., 510(k) submissions, PMAs, IDEs, international dossiers.

6. Anticipate and establish schedules for regulatory submissions.

7. Ensure that new product submissions meet the minimum regulatory threshold to avoid deficiency letters and refusal to file letters from FDA.

8. Manage interaction with FDA regarding submission approval status/issues for pending submissions.

9. Negotiate new product submission requirements with FDA or foreign officials.

10. Monitor regulatory developments from the FDA, foreign authorities and competitors.

11. Provide detailed budgets to senior management for complex regulatory submissions.

12. Interview applicants and recommend for hire. Evaluate performance, initiate promotions, pay increases and disciplinary actions.

13. Perform due diligence on Regulatory information for potential acquisitions and/or distribution arrangements.

14. Manage the RA integration of acquisitions into USS.



Requirements:

MINIMUM REQUIREMENTS:

A Bachelor of Science degree in Physical Sciences or equivalent plus four years previous related experience. A broad knowledge of biology, chemistry or related field is necessary. Excellent verbal and written communication, as well as organizational skills required. Good computer skills amust.




To apply online, please use the following link: