181 Regulatory Affairs Associate (181 RA) 

Location: Nashville, TN

Our client is a regenerative medicine company committed to developing and marketing, worldwide, the highest quality therapeutic medical products for the treatment of conditions where bone regeneration is critical. Their goal is to be a world-leader in novel, therapeutic proteins used in the surgical treatment of selected conditions to include, but not limited to, oromaxilofacial, orthopedic, sports medicine, trauma, and spine. The Company is well-established, having just received FDA approval on its lead product and has established a marketing alliance with a major pharmaceutical company.

This position is responsible for managing assigned regulatory activities, including ensuring company documentation and products meet regulatory requirements, assisting in the preparation of U.S. and international regulatory filings for new and modified products, managing the complaint handling and reporting system, assisting in device recalls and market withdrawals, preparing export certificates, product listings and establishment registrations, reviewing labeling, advertising and promotional materials, and assisting other functional groups.

Key responsibilities include:

·  Assist in the preparation of U.S. and international regulatory filings.

·  Provide regulatory advice and guidance to product/project teams and other functional groups

·  Participate in design control activities, including attendance at multi-functional meetings, determining regulatory pathways, reviewing and approving design control documentation, participating in design reviews, and other assistance as requested by the project team leader.

·  Review and approve product labeling and promotional materials to ensure compliance with regulatory submissions and applicable laws and regulations.

·  Receive, review, and respond to complaints and maintain complaint files. Prepare MDR/Vigilance reports for review by senior Regulatory Affairs staff.

·  Prepare export certificates, medical device listings, and annual establishment registrations.

·  Review and approve change control documentation, and determine submission and reporting requirements for changes.

·  Review and approve manufacturing documentation, validation protocols and reports for R&D and manufacturing studies, Quality System documentation (such as SOPs, work instructions, policies, and forms), and contracts, protocols, reports, and other documentation for contract facilities.

·  Maintain Regulatory Affairs files and regulatory database.

·  Prepare and maintain regulatory activity logs.

·  Miscellaneous regulatory compliance issues and special projects, as required.

This position is responsible for managing assigned regulatory activities, including ensuring company documentation and products meet regulatory requirements, assisting in the preparation of U.S. and international regulatory filings for new and modified products, managing the complaint handling and reporting system, assisting in device recalls and market withdrawals, preparing export certificates, product listings and establishment registrations, reviewing labeling, advertising and promotional materials, and assisting other functional groups.

Position Requirements:

The preferred candidate will possess a BS/BA degree in a relevant field and A minimum of three years experience within the regulated industry (Medical Device and/or Pharmaceutical); experience with orthopedic products a plus. Working knowledge of medical device and/or drug development processes, and U.S., EU, and Canadian laws, regulations, guidance documents, and practices for drugs, medical devices, and quality systems. Effective communication skills, both verbal and written are essential.

Useful technical skills/knowledge base includes:  

·  Experience with international regulatory submissions;

·  Good Laboratory Practices Standards;

·  Standards and standard setting bodies to include:
     oISO
     oAAMI
     oASTM
     oICH
     oUSP

You can email resumes to Admin@LegacyMedSearch.com 

ABOUT Legacy MedSearch:
Retained Recruiting Firm specializing in the Emerging Medical Technology. Our firm is hired by medical device and imaging manufacturers to find senior-level executives in specialized fields such as surgery, diagnostic & therapeutic imaging & radiology, including CT, MR, PET, DR/CR, Ultrasound, HIFU, Fluoroscopy, PACS, Mammography, MIS & LIS procedures. We work with manufacturers of a variety of implants & technologies: IMD, AIMD and Class I, Class II and Class III devices with special emphasis on orthopedics, Navigation (IGS, CAS, DBS, Surgical Robotics, NeuroScience), neurosurgery, radiology, neuroscience, cardiology and cardiovascular and other emerging medical technology (VC, PMA, 510(k) & IDE device classes).
Our office recruits: Product Managers, Engineers (Product Development, Design, Manufacturing, Electrical and Software engineers), Marketing and Sales Executives, Operations, Quality, Regulatory, Research Professionals.  In the past 18 months, we have placed 48 professionals in start-up, emerging & leading medical companies.For additional information, please visit our website at www.LegacyMedSearch.com