Camargo Pharmaceutical Services is now seeking a Director of Regulatory Medical Device to provide oversight in guiding our regulatory teams on device related requirements and strategies. The Director of Regulatory Medical Device serves as the primary device expert for developing medical device regulatory strategies in combination product development and assists with the preparation and submission of regulatory documents for devices and Combination Products. We’re seeking someone who can evaluate medical device regulations and provides assessments of the impact of new and changing regulations on strategies to rapidly bring combination products to market.
This is a great opportunity for someone who is looking to join a growing company that is the already the acknowledged market leader in the dynamic and expanding drug development services arena focusing on the 505(b)(2) approval pathway.
You might be a good fit if you have:
Worked in a team environment to oversee the process of preparing device-related information in combination product submissions to domestic and international regulatory bodies and manages the process from inception to approval.
Provided oversight and regulatory advice throughout the device development life cycle, including guidance on facilitating design controls, risk management and post-market activities.
Provided regulatory review of Human Factor study/clinical protocols, investigator's brochures, labeling, and integrated summary documents for adequacy.
Enjoyed working in a collaborative, energetic, team-oriented environment that is poised for exciting future growth.
Qualified candidates must have 8-10 years’ experience serving as subject matter expert on combination products to various regulatory teams on device development and regulatory strategy around clearance/approval (e.g. 510(k), PMA, PMA Supplements, pre-and post-approval studies, etc.).
This position is based in Boston (Cambridge).
Qualified applicants should submit their cover letter and CV no later than September 30, 2017.
We are the most experienced global strategist providing comprehensive drug development services specialized for the 505(b)(2) approval pathway and global equivalent processes. Camargo leads the largest percentage of 505(b)(2) submissions of any team submitting to the FDA, having guided more than 200 NDA and ANDA approvals. We routinely hold 3-5 pre-IND meetings a month and work across more than ...25 countries. Camargo Pharmaceutical Services is headquartered in Cincinnati, Ohio with an office in Durham, North Carolina. From evaluating and identifying candidates, to providing comprehensive CMC, pharmacokinetics and clinical development services, we do it all!
Camargo is proud of our cross-functional teams and we cultivate a learning environment that supports one another. We offer a rich benefits package including medical, dental, and vision coverage, life insurance, short term and long term disability, PTO days and company paid holidays among other perks. Please visit our Careers page to learn about our culture and why our team members enjoy working at Camargo.