Regulatory Open Forum

Hello,

I'm with Biomedical Search Consultants, a firm that specializes in placing talent in the medical device field.  I'm currently recruiting for a Regulatory Affairs Specialist (see below).  If this opportunity is of interest to you, kindly email me your updated resume and contact information, and I will follow up with you to further check your interest.  If this opportunity is not a fit for you, please forward to any interested colleagues. 

Thank you for your consideration.

Sincerely,

Kathy Provost

Managing Director

Biomedical Search Consultants

a Division of King & Bishop

Waltham, MA, USA

Ph: 978/952-6425

Em: kprovost@biomedicalsearchconsultants.com

www.biomedicalsearchconsultants.com

Regulatory Affairs Specialist (Greater Boston area)

Reporting to the VP of Regulatory and Quality, this position will play a key role in this fast-growth medical device company which boasts excellent investment backing, a proven executive management team and FDA approved products that are well-respected in the surgical arena.

Responsibilities

This position is responsible for creation, preparation and coordination of regulatory submissions and approvals to introduce products in the domestic and international markets.

• Understand and interpret regulatory requirements in various geographies
• Prepare document packages for regulatory submissions including 510(k)s Design Dossiers, Device License Applications, Investigational Device Exemptions, and Pre-market Approval applications 
• Track and coordinate regulatory submission activities to ensure timelines and commitments are met
• Coordinate responses to regulatory agencies and notified bodies as part of the submission and approval processes
• Review and approve Engineering Change Orders in accordance with regulatory requirements
• Participate in new product development teams and communicate regulatory requirements for product development; facilitate internal compliance with those requirements
• Review and approve test protocols to support regulatory submissions
• Review device labeling and advertising material for compliance with submissions
• Assist in regulatory compliance activities
• Maintain regulatory files 
• Perform Internal Audits of the Quality System

Requirements

• Bachelor of Science in Engineering or Science. Advanced degree preferred.
• Minimum 3-5 years of relevant industry experience
• Knowledge of applicable domestic and international regulations
• Regulatory submission experience in various geographies
• Regulatory compliance experience in the medical device area preferred
• Must have good oral communication and strong writing skills
• Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have a high attention to detail
• Good understanding of regulations and guidelines for development, manufacturing and labeling of medical devices
• Working knowledge of GMPs and GCPs

Please submit resume to: kprovost@biomedicalsearchconsultants.com

For more information, please visit www.biomedicalsearchconsultants.com