Regulatory Affairs Coordinator

Company: Haemonetics Corporation
Location: Boston
Posted on: November 22, 2021

Job Description:

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.

Job Details

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, etc).
• 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 market.
• 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 inbox.
• 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 documentation environment.
  • Technical aptitude and data management experience is required
  • 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