Senior Regulatory Affairs Specialis

Confidential Company  •  Cambridge, MA

Salary depends on experience
Posted on 04/21/18
Confidential Company
Cambridge, MA
Salary depends on experience
Posted on 04/21/18

Job Highlights

Candidates who need to relocate will be considered for this role

Candidates requiring visa sponsorship will not be considered for this role

Beneficial Qualifications (Not required, but nice to have)

  • Graduate degree in Regulatory Affairs
  • Experience in submitting Q submissions, Pre-IDEs, and IDEs
  • Experience working with capital equipment
  • Experience in Class III U.S. submissions

About the Role

The Senior Regulatory Affairs Specialist is responsible for planning, managing, composing, and submitting regulatory documentation to the FDA, notified body, and providing information for other country-specific product registrations. The position is also responsible for ensuring continued compliance with regulatory agency approvals.

Responsibilities include:

?Develops domestic and international strategies for regulatory approval of company products

?Researches and advises company on country-specific international product registration and compliance related requirements

?Coordinates, composes, compiles, and submits U.S., E.U. and international regulatory filings for new and modified company products, including 510(k)s, PMA supplements, IDEs, CE Mark technical files & design dossiers and updates, and provides information for other country-specific product registrations

?Technical reviews of test protocols and reports and other submission deliverables for inclusion in regulatory filings

?Assessment of labeling, advertising, and promotional materials for regulatory compliance and support of claims

?Review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings

?Represents RA on cross functional product development and manufacturing support teams

?Works with clinical affairs for reporting of A/E's associated with clinical trials

?Assists with customer complaint, MDR, and field action-related tasks as assigned

?Works on and/or leads complex regulatory projects as assigned

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