Regulatory Affairs Manager / Senior RA Specialist - (US-MA-Burlington - 01805)

Minimum Education: None
Jobcode: 56305022
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Candidate will be responsible for developing and implementing documentation policies and practices that comply with Federal and International regulatory agencies with respect to therapeutic, medical and diagnostic device products. Candidate will prepare regulatory submissions for new products/product changes to ensure timely approval for clinical studies and market release and will follow up with regulatory agencies on these submissions. Candidate will serve as regulatory affairs representative to product development teams to provide guidance on regulatory issues and filing activities. Candidate will be responsible for producing document packages for regulatory submission (including FDA, 510(K), IDE, PMA, CE Technical Files and Design Dossiers) and will review documents that may impact regulatory submissions/approvals. Candidate will also assist in the preparation of protocols and documents for clinical studies and will assist with the coordination of clinical studies with respect to good scientific principles and pertinent government regulations.



Job Responsibilities :



The Manager Regulatory Affairs (or Senior Regulatory Affairs Specialist) will report directly to the Vice President of Regulatory Affairs and have the following primary responsibilities:



Prepare regulatory (510k, IDE, PMA) submissions for new products and product changes as required to ensure timely approvals for clinical studies and market release.
Responsible for assembling document packages for regulatory submissions, including FDA 510(K), IDE, PMA, CE Technical Files and Design Dossiers, Shonin and Ichihen and internal letters to file. Will also prepare technical information for device license/registration as defined by country specific requirements.
Responsible for submitting device listing and establishment registration to FDA.
Review significant product submissions and may negotiate submission issues with agency personnel.
Provide support to currently marketed products as necessary to include: reviewing of engineering changes, labeling, promotional material, product changes and documentation for changes requiring government approval.
Provide on-going support to product development teams for regulatory issues and questions.
Review ECOs, NCMRs, CAPAs that may impact regulatory submissions and approvals including design and manufacturing changes, labeling, web page content and advertisements.
Assist in the preparation of protocols and documents for clinical studies, entailing communication with consultants such as surgeons and outside statisticians.
Initiate, follow-up, negotiate and resolve issues regarding current and future submissions with appropriate regulatory agency.
Maintain constant contact with clinical sites to expedite the exchange of information and ensures that clinical studies are kept on schedule. Coordinate internal and external resources in the conduct of clinical studies in accordance with good scientific principles and pertinent government regulations.
Review and approve technical data, and verifies accuracy of clinical data and execution of clinical projects to regulatory authorities.
Review regulatory publications to keep apprised of new regulatory developments.
Serves as regulatory affairs representative on assigned teams to provide input on phase I, II, and III filing activities and to ensure that report systems are maintained.
Coordinates with other departments, corporate or marketing partners, and international offices to achieve project goals.
Develop, implement, and review current policies and practices issued by Federal and international regulatory agencies.





Candidate Requirements :



Bachelor's degree from four-year college or university or equivalent experience
At least three years related experience in a regulatory role
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
Ability to write reports, business correspondence, and procedure manuals.
Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.