Regulatory Affairs Coordinator
Company: Haemonetics Corporation
Posted on: November 22, 2021
We are constantly looking to add to our core talent. If you are
seeking a career that is challenging and rewarding, a work
environment that is diverse and dynamic, look no further -
Haemonetics is your employer of choice.
The Regulatory Affairs Coordinator - Hospital/Blood Center is
responsible for the coordination and tracking of day-to-day
regulatory related activities to ensure timely submission and
compliance with local regulations. Will assist in initiation,
monitoring and track to completion all phases of regulatory
activity. Provides assistance to regulatory personnel with
documentation, data and other tasks as directed.
The incumbent may be asked to perform other function-related
activities in addition to the below mentioned responsibilities as
reasonably required by business needs. This is a hybrid role based
out of Boston, MA. Work from home flexibility.
- Coordinate, obtain, legalize, compile and distribute documents
needed to support global regulatory submissions. Organize and
maintain submission files.
- Maintain meta data in product database for registered products
(ie. FDA submission dates CE Mark dates, international licenses,
- Maintain and renew U.S. FDA and Health Canada establishment
registrations and product listings.
- Prepare, request and track government certifications to ensure
smooth transition with registration of new products in global
- Assist with audit preparations.
- Provide metrics and reports to support RA needs. Submit
requisitions and Purchase Orders.
- Review and update SOPs and related documents.
- Monitor and maintain regulatory affairs general email
- Assist in preparation, review, and submission of new and/or
renewed U.S. state manufacturer/distributor/wholesaler licenses for
medical devices & pharmaceuticals.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Technical College Degree (AA) Science, Political Science,
English or similar is required. BA/BS degree preferred.
- Minimum of 1 year In regulatory, quality, and or legal
- Technical aptitude and data management experience is
- Detail oriented with the ability to administer and coordinate
multiple inquiries and requests.
- Regulatory Affairs Certification (RAC) Preferred
- American Society of Quality (ASQ) Preferred
KNOWLEDGE, SKILLS AND ABILITIES
- Experience in a regulated environment
- International RA Experience is a plus
- Excellent organizational skills
EEO Policy Statement
Keywords: Haemonetics Corporation, Boston , Regulatory Affairs Coordinator, Other , Boston, Massachusetts
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