Description
Exciting Senior International Regulatory Affairs Specialist Opportunity with Global Medical Device Company in Massachusetts!!!The Senior International Regulatory Affairs Specialist compiles and writes submission documents for product licensing and registration in international markets.
Responsibilities:
- Participate and partner with R&D, Marketing and other required groups
- Assess and compile appropriate technical documents for regulatory submissions
- Coordinates and tracks the notarization and legalization of regulatory documents
- Coordinates the preparation of Certificates to Foreign Government, Certificates of Free Sale, and Declarations of Conformity for international registrations.
- Communicates with Asia Pacific, Latin America and European regulatory groups, as well as International Distributors to compile registration requirements.
- Prepares regulatory submissions for approval according to country registration requirements (Asia Pacific, Latin America, and European regions).
- Identify appropriate standards for application in support of product development.
- Maintain knowledge of regulatory guidance by attending seminars and other appropriate training courses.
- Provide input and expertise during regulatory agency audits and draft responses to support audit findings
Requirements:
- Minimum of a Bachelor's degree preferably in a technical discipline
- 4+ years experience in regulatory affairs within the medical device industry
- Must have proven experience in International Regulatory Affairs submissions
- CE technical file experience preferred
- Strong attention to detail, ability to multi-task
This is an exciting opportunity for a Regulatory Affairs Specialist in the Medical Device field.
Contact me today!
Deneen Jackson
To find out more about Real please visit www.realstaffing.com