Sr. Regulatory Affairs Specialist

MedFocus is a respected provider of clinical personnel to the leading pharmaceutical and biotech companies across the U.S. We provide competitive salary and benefit packages along with the chance to work with the most sought after companies in the industry.

One of our Medical Device clients in CT is looking for Senior Regulatory Affairs Specialist to join their team for an exciting 6 month contract to hire opportunity!

Perform diversified duties under general direction in order to meet domestic and international product submission and/or registration requirements

ESSENTIAL FUNCTIONS:

1. Track new and existing product development for a particular product category.

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

3. Determine product submission requirements and apprise management to ensure adequate data is developed for product submission.

4. Discuss new product safety and efficacy testing regimens with Engineering and Quality Assurance departments for both simple and complex submissions.

5. Provide direction and support to the Regulatory Affairs Associates.

6. Prepare product registration dossiers, e.g., 510(k) submissions, PMAs, IDEs, international dossiers, for both simple and complex projects.

7. Ensure that new product submissions meet the minimum regulatory threshold to avoid deficiency letters and "refusal to file" letters from FDA.  Contact FDA officials regarding submission approval status/issues for pending submissions.

8. Ensure that marketing label claims are supported by test data.

9. Negotiate new product submission requirements with FDA officials.

10. Correspond with international marketing affiliates and distributors regarding requirements, dossiers and registration status.

11. Correspond with international customer service and other departments, as necessary, regarding transfer of registration materials (samples, dossiers) to affiliates and distributors.

12. Obtain product export certificates from U.S. FDA

Education required/ preferred:  Bachelor of Science degree in Physical Sciences

Experience:  Two years previous related experience

Preferred Skills/Qualifications:  Broad knowledge of biology, chemistry or related field

Skills/Competencies:  Excellent verbal and written communication, as well as organizational skills, Good Computer Skills