Sr. Regulatory Affairs Specialist at Warwick

Job Description

Sr. Regulatory Affairs Specialist
Davol Inc.
Warwick, RI

The position of Regulatory Affairs Specialist will provide technical and administrative regulatory support to ensure timely introduction of new products subject to medical products regulations. Provide regulatory support to marketed products.

Essential Job Functions:
Prepare and submit applications to the FDA for clinical testing and marketing of new/modified medical devices (e.g., 510(k)s, IDEs, PMAs, PMA supplemental applications)
Support in determination of the appropriate regulatory submission requirements and strategies for new or modified products. Prepare required documentation as needed (e.g., No 510(k) Rationales, international change notifications).
Coordinate review of FDA submissions and test protocols with Corporate Regulatory, Medical and Legal Departments, and respond to any questions posed by these departments or the FDA.
Prepare application documentation for international marketing approvals (i.e. CE Mark Technical files and Dossiers, JSTD, International Dossier).
Assist Product Development and Quality Assurance in planning pre-clinical studies and bench testing that will ultimately be used in regulatory submissions.
Assist in the review of proposals for clinical design validations, clinical field trials and customer preference tests.
Represent regulatory affairs on product development teams to provide direction with respect to regulatory/clinical requirements and strategy.
Assist in development of new product instructions for use/promotional material. Review product labeling for compliance with medical device regulations and Division/Corporate Policies.
Provide marketed product regulatory support for change management activities, product registrations, and business improvement activities.
Support due diligence and business integration activities as assigned.
Support the development and implementation of Davol and Bard regulatory processes, procedures, and standards as assigned.
Special projects as assigned.

- B.S. required with emphasis on Life Sciences or equivalent
Senior RA Specialist: Minimum of four years knowledge and experience with regulatory requirements for medical devices including submission of IDEs, PMAs, 510(k)s, CE mark technical files and design dossiers.
RA Specialist: Minimum of two years knowledge and experience with regulatory requirements for medical devices including submission of IDEs, PMAs, 510(k)s, CE mark technical files and design dossiers.
Solid knowledge in FDA, EU regulations for medical device and combination product.
Previous experience in managing complex, multi-facet projects.
Good oral and written communications skills - analytical thinking and technical writing; ability to work on cross-functional teams; ability to manage several parallel deliverables.
Working knowledge of statistics and electronic documentation and information systems.
Minimum supervision required, can work independently.
Ability to travel as needed.

Job Requirements

 
Country: USA, State: Rhode Island, City: Warwick, Company: CR Bard.