Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Requirements

• B.S. / B.A. degree required or a minimum 7 years of regulatory/quality experience in the medical device or life sciences industry.
• Minimum 5 years experience in regulatory/quality within the medical device or life sciences industry.

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.
• Represent Regulatory Affairs on project teams and in key meetings and decision making processes.
• Assist with pre-market and post-market filings (510(k), Q-submissions, 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.
• Manage submission deliverables that are both self-owned and owned by cross-functional team members to ensure quality and timely submissions.
• Review submission decisions/content issues with manager.
• Provide assistance in planning, creating, organizing and interpreting regulatory documents for submission to various regulatory agencies.
• Ensure timely and professional communication with contacts from 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.
• Partner with Marketing and Development teams to provide support to currently-marketed products as necessary.
• Compile and submit documentation as required in support of marketing initiatives.
• Review marketing and sales promotional materials for regulatory impact.
• Performs other duties as required.

Preferred Qualifications

• Effective verbal and written communication skills.
• Proficient technical writing skills.
• RAC Certification preferred.
• Knowledge of regulatory guidelines and requirements (domestic and international).
• Experience with reviewing ECOs, Requirements, and Specification Documents.
• Understanding of 21 CFR 820, CMDR, ISO 13485, IEC 62304, ISO 14971, MDD, MDR.
• Experience with Software in a Medical Device (SiMD) and/or Software as a Medical Device (SaMD).
• Experience with Interoperable medical devices.
• 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 operate effectively in a fast-paced environment.
• Ability to generate and maintain accurate records.