RA Specialist wanting Management (Medical Devices

Company Description

If you are looking for a well known company that takes a premium on the clientele then continue reading.We want to hear from high impact, low maintenance individuals that want to continue both personal and professional growth.

People looking for a Career and not just a job should apply.

My client is a Medical Device Manufacturer with a presence both domestically as well as international and due to continuous growth are seeking a Regulatory Affairs Manager.

This is a great opportunity for a Sr RA Specialist looking to get into Management.

Responsible for the planning, direction and execution of regulatory activities for EU, US and ROW.

Develops and implements strategies with the goal of approval/clearance of regulatory submissions.

Manage regulatory teams and provide guidance to R&D, Clinical, & QA regarding submission and compliance requirements.

Prepare responses to inquiries from regulatory authorities.

Negotiate with outside regulatory authorities as needed to resolve key regulatory issues and secure approvals/clearances in a timely manner.

Submit supplements and amendments to update registered product information.

Experience writing, and gaining acceptance of 510k submissions for FDA

B.S. degree

Minimum of 10 years of medical device regulatory affairs

Travel approximately 10-15% internationally and domestically

Legally able to work in the United States

We look forward to receiving your application!
All your information will be kept confidential according to EEO guidelines.

For confidential consideration please email your resume to [email protected]