Careers atAgile Search, Inc.

Due to the growth and success of our medical device client, we currently have a rare opportunity for a proven leader to step in and Direct of a high performing regulatory affairs team.   This an opportunity for someone who loves to mentor, motivate, and LEAD a team of professionals (approx 7 RA Staff).   Our client has multiple commercial products on the market and is in the process of launching several more over the next 2-3 years (both PMA and 510K type products).   This is NOT a backfill, but a newly created leadership position.  

Summary of Job Description:
The Director, Regulatory Affairs for this established, yet highly innovative medical technology company will manage regulatory staff and activities for assigned projects and participate as the lead regulatory representative and develop and implement regulatory submission strategies.

Requirements:

Demonstrated success leading regulatory personnel in a dynamic medical device environment-- this is a leadership role.

Must have significant knowledge and ideally hands-on experience with PMA submissions.  **Strong management experience will overcome a lack of PMA experience.

Extensive and thorough knowledge of regulations/guidelines governing the development of medical devices including Quality Systems requirements and the ability to mentor and guide others in the application of these principles.

Demonstrated experience having primary responsibility for regulatory submissions, including successful FDA interface/negotiations.

Expertise in development, review, and approval of labeling and promotional material.

Must have knowledge of the U.S.A. Federal Regulations for medical devices including those applicable to the import/export of devices.

Must have knowledge with the requirements for medical device registration/licensing in the EU, Japan, Canada, Australia, Latin America and Asia/Pacific.

Must have exceptional written & oral communication skills and the ability to communicate appropriately with different engineering teams, Product Management, vendors and partners, and customers.

Must be able to travel occasionally to meet with customers / project teams.
 

Education: 
B.A./B.S. or advanced degree in scientific/life-sciences or engineering field with applicable industry experience and direct regulatory affairs experience with particular focus on U.S. FDA.

Experience:
10+ years of relevant regulatory affairs experience, with at least 4 years in a management role, leading direct reports in a regulatory function. 
Additional competency and exposure in clinical affairs and clinical research planning is desired.