Regulatory Affairs Associate
(Greater Boston
area)
Our client is a medical device leader in
the orthopedic field. Reporting to the
Director of Quality and Regulatory, this position will
play a key role in this fast-growth 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 (domestic and international)
- Prepare document
packages for regulatory submissions including 510(k)s Design Dossiers,
Device License Applications, Investigational Device Exemptions, and
Pre-market Approval applications
- Direct and
organize regulatory submission activities to ensure timelines and
commitments are met
- Integrate
responses to regulatory agencies and notified bodies as part of the
submission and approval processes.
- Draft
abstract/bench papers for publications
- Review and
approve Engineering Change Orders in accordance with regulatory
requirements
- Facilitate
internal compliance with regulatory requirements for product development
and be an integral part of the product development teams.
- Review and
approve test protocols to support regulatory submissions
- Oversee device
labeling and advertising material for compliance with submissions
- Collaborate in
Regulatory compliance activities
- Maintain
regulatory files
- Perform Internal
Audits of the Quality System
Requirements
- Bachelor degree
in Engineering or Science. Advanced degree preferred.
- Experience
writing abstracts, bench/clinical papers desired
- 3+ years of
relevant industry experience (regulatory compliance experience in the
medical device preferred)
- Knowledge of
applicable domestic and international regulations
- Strong verbal
and writing communication skills
- Ability to work
in a team environment, execute responsibilities with minimal direct
supervision, and have a high attention to detail.
- Demonstrated
understanding of regulations and guidelines for development, manufacturing
and labeling of medical devices
- Demonstrated
knowledge of GMPs and GCPs
Please
submit resume to: kprovost@biomedicalsearchconsultants.com
For
more information, please visit www.biomedicalsearchconsultants.com