Sr. Regulatory Affairs Specialist (Hybrid - Acton, MA)

Job Summary

Position Overview: The Senior Regulatory Affairs Specialist will lead activities which support both domestic and international regulatory registrations and submissions activities including working with Marketing, New Product Development, Manufacturing and Engineering.

Responsibilities

• Support initiatives to ensure regulatory approval of medical devices in both domestic and international markets.
• Provide regulatory affairs support for all aspects of product development, product manufacturing, and/or clinical studies including pre-market, post-market and physician initiated studies.
• Provide Regulatory support to on-going compliance and corporate initiatives.
• Partner with Marketing and Development teams to provide support to currently-marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval.
• Compile and submit documentation as required in support of marketing initiatives.
• Review marketing and sales promotional materials for regulatory impact, including: Promotional materials for journals and other media Trade show booths, materials for distribution Sales talking points, etc.
• Review product packaging and labeling changes for regulatory impact, including: US labels in English Review of translations with certified translators Vendor documentation, certification, and fitness for quality
• Represent Regulatory Affairs on project teams and in key meetings and decision making processes regarding labeling and promotion.
• Aid in pre-market and post-market filings (510(k), IDE, PMA, PMA updates, CE Marking, Canadian Registrations, EU Registrations, and ROW registrations).
• Prepare submissions and reports for FDA and support other international agencies as required.
• Review submission decisions/content issues with manager.
• Provide assistance in planning, creating, organizing and interpreting regulatory documents for submission to various regulatory agencies.
• Review and approve project documentation such as specifications, procedures, schedules, test protocols and reports, validations, etc.
• Evaluate, communicate, and present change assessments to the organization to ensure timely implementation in support of continued compliance.
• Review, evaluate and approve Engineering Change Orders (ECO) especially those concerning significant changes and revisions.
• Performs other duties as required.

Education And Experience

Minimum Requirements: 5+ years of regulatory medical device industry experience. RAC Certification preferred. Knowledge of regulatory guidelines and requirements (domestic and international).

Preferred Skills And Competencies

• Effective verbal and written communication skills
• Experience with reviewing ECOs, Requirements, and Specification Documents
• Understanding of 21 CFR 820, CMDR, ISO 13485, MDD
• Team player ready to work hard on a dedicated team that has the safety of the patient as priority #1
• Ability to communicate at multiple levels of an organization
• PC skill, word processing, spreadsheet, database, specifically: Word, Excel, PowerPoint, Visio, Project
• Ability to organize and manage multiple priorities
• Ability to generate and maintain accurate records