Senior Regulatory Affairs Specialist (Remote/Flexible)

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.
• 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. 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.
• Performs other duties as required.

Minimum 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.

Preferred Skills and Competencies:

• 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.

NOTE: This position is eligible for 100% remote working arrangements (may work from home/virtually 100%; may also work hybrid on-site/virtual as desired). #LI-Remote 

Additional Information: