Regulatory Affairs Manager
Location: Greater Philadelphia Region
Contact: Janene Cleary, firstname.lastname@example.org
Regulatory Affairs Manager | Medical Device Company
This Regulatory Affairs Manager search is being conducted on behalf of Medical Device client who has FDA approval for the treatment of depression. This treatment has the CE mark of approval and is used globally.
In this role, one will be responsible for preparing, filing and gaining approval of submissions to regulatory authorities in the US, European Union, Asia and the Middle East. The manager will maintain marketability of existing products and ensures department objectives are met.
This position requires a working knowledge of regulations and guidances. This individual assists in refining Regulatory Affairs processes and provides regulatory expertise and compliance for all global product development, clinical development and Marketing functions.
The ideal candidate must have device experience (510 K), basic knowledge of US and Global regulatory regulations (EU OR Asia Pacific), along with Ad & Promo.
This individual must be enthusiastic, positive, dependable, flexible and able to build relationships working as part of a team and working independently.
Location: This company is located in the metro Philadelphia area in an area that allows for an easy commute to local major roadways.
ADDITIONAL INFORMATION ABOUT THIS COMPANY AND ROLE:
- Privately held medical device company with 120 employees.
- The environment is high-energy.
- Reports into the Director of Regulatory Affairs.
HIGHLIGHTS OF RESPONSIBILITIES:
- Manage preparation and filing of International regulatory submissions for the European Union, Asia and the Middle East, utilizing clinical study data as well as verification and validation test data.
- Manage preparation and filing of 510(K), IDE and FDA submissions.
- Manage directed regulatory projects, developing and executing regulatory plans including product changes.
- Work proactively with project teams and RA management to manage and resolve submission issues.
- Write, review and edit regulatory submissions as appropriate and format, publish and submit documentation in accordance with requirements and regulatory guidance.
- Create regulatory strategies for submissions, protocol development and Clinical studies to ensure most efficient approval times.
- Work with Product Development, Clinical Affairs, Quality, Management and other areas of the organization to obtain relevant information and subsequent review of submission content as needed.
- Manage and maintain Technical file for CE marking.
- Manage and maintain STED documents for OUS Submissions.
- Manage the archival and tracking of regulatory documentation, including: correspondence, labeling, data packages, forms, submissions and related materials submitted to regulatory agencies.
- Assist in approval of product labeling, technical publications and promotional materials, assuring regulatory requirements are met, safety warnings and precautions are adequate, and all product claims are properly supported. Recommend new or modified product use and warning labeling changes in response to new information.
DESIRED SKILLS AND QUALIFICATIONS:
- BS or BA degree in life sciences or equivalent.
- Minimum 5 years’ experience in Regulatory Affairs in the medical device industry or pharma. experience with psychiatry or neurology product is ideal.
- Evidence of strong collaborative and team leadership experience.
- Cross-functional experiences in working with teams and/or leading and supporting product development and marketing teams.
- Knowledge of medical device requirements including QSR, CAMDCAS, ISO 9001/13485.
- Experience in a start-up or small company environment is preferred.
- Close involvement in at least one complete medical device product development cycle from product development through marketed product.
Janene Cleary, Director Life Sciences Recruiting
Phone: 267-483-5233 x 103
The Bandish Group, LLC
Life Sciences Executive Search
1432 Easton Road, Warrington, PA 18976