Regulatory Affairs Operation Specialist Job in Boston, Massachusetts US
About our Client:
This position is with a Global Medical Technology company with world-class benefits, top tier compensation and a winning culture. And! this role is within one of the fastest growing divisions of the company. Please, only apply if you have 1+ year of medical device in RA or QA. Thank you!
As a Regulatory Affairs Operations Specialist, your responsibilities encompass the support of worldwide product registrations and support of Regulatory activities including but not limited to:
- Organization and preparation of final regulatory filings (e.g. product submissions and site/establishment registrations)
- Under direction review change control documents and ascertain regulatory impact
- Obtaining/Maintaining Certificates of Foreign Government (CFG)/Certificates of Free Sale (CFS)
- Requesting and routing registration fees to appropriate parties
- Understand and recommend strategies based on current local registration requirements and applicable industry standards
- Understand competitive technologies
- Understand local country quality requirements
MINIMUM REQUIREMENTS:
Education: Bachelors Degree in a Scientific discipline
Experience: 1-3 years Regulatory Affairs or Compliance
- Strong organizational skills with the ability to problem solve
- Minimum 1 year in a Regulatory function, with experience with Foreign Country Registrations
- Team oriented and an ability to work well with others
- Excellent written and oral communication skills
- Time required, up to 10%
October 27, 2009
• Tags: Massachusetts Us, Regulatory Affairs Operation Specialist Job in Boston • Posted in: General