Regulatory Affairs Manager

The Client’s mission is to bring the medical marvel of regenerative medicine to patients and to standardize its use in everyday medical care.  With over 200,000 patients treated with their flagship product, they feel that their goal of introducing regenerative medicine to the world has been achieved.  They feel that millions of patients still need  to receive the benefits of advanced medicine modalities.  The Client is continuing to expand their staff to position themselves for additional growth.  As part of this expansion, they have created the position of REGULATORY AFFAIRS MANAGER to lead sales and marketing compliance initiatives and manage the adverse events reporting program

The REGULATORY AFFAIRS MANAGER will:

• Manage the company’s sales and marketing compliance program


• Review advertising and promotion materials, and those of competitors


• Manage the adverse event program, reviewing customer complaint investigation results; assessing and investigating potential adverse events and incident reports..


• Manage recall and removal activities; assess and document health hazard assessments..


• Resolve regulatory compliance issues occurring as a result of data discrepancies and manufacturing nonconformances.  Support CAPA and quality investigations.


• Review Quality Systems programs, providing regulatory SOPs to support medical device and biologics quality systems.


• Ensure regulatory compliance with product development, validation and commercialization activities subject to US, EMEA and other international regulations.

The REGULATORY AFFAIRS MANAGER will have:

• BS in Life Science or Engineering


• 10+ years experience in the device/biotech industry, with a minimum of 7 years regulatory experience with compliance related activities


• Working knowledge of US Quality System regulatory standards for device and biologic products


• Knowledge of FDA and International device/biologics regulations


• Thorough understanding of and experience with biologics/biotech product development and manufacturing


• Experience with commercially available products, including sales and marketing promotion and compliance activities


• Experience with adverse event reporting


• Experience with managing and authoring statutory regulatory reports and documents


• Strong organizational, interpersonal and written and oral communication skills


• Demonstrated and leadership and project management skills


• Greater Boston Area  residency (strongly preferred)