Regulatory Affairs Manager

Changing lives. Building Careers.

Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.

**Responsibilities**:

- Use in-depth applied knowledge and understanding of US domestic and international medical device, regulations (including 510k, and International dossiers) to assume major responsibility for supporting new product development.
- Utilize expert base of knowledge and understanding of regulatory requirements, documentation, language, and the submission filing process to lead and mentor a focused team to ensure that the product portfolio and the required regulatory documentation is optimized for the business.
- Independently evaluate regulatory issues and perform research, as required, to develop and implement regulatory strategies for the assigned program; Maintain up to date and expert knowledge of regulatory requirements, comment on draft regulatory guidance, and communicate changes in regulatory information and develop proposals to address changes, as needed. Implement regulatory strategies to revise technical documentation for existing and new regulatory submissions.
- Manage the development of US and International regulatory strategies and verification and validation activities for assigned product submissions.
- Author submissions (510k, MDR files, MDD changes) independently. Ensure timeliness of regulatory submissions according to business needs. This includes ensuring prompt follow-up to the questions and requests received from regulators.
- Actively lead and/or manage the regulatory aspects of upcoming audits and certification reviews with all Company designated Notified Bodies. Communicate with the Company’s Notified Bodies regarding regulatory issues/questions and schedule Technical Documentation/Technical File reviews.
- Identify strategies to ensure compliance and maintenance of Regulatory Affairs product files (design dossiers, periodic regulatory reports) to support compliance with regulatory requirements.
- Develop regulatory strategies and internal processes around ad/promo reviews based on regulations; Provide expert guidance to teams and oversee review of promotional and advertising material for adherence to approved product claims and regulatory compliance.
- Manage RA leads as well as manage partnership with Product Development, Manufacturing and QA/QC to ensure overall compliance with US, Canadian, European, and International regulations.
- Manage rollouts of product changes with corporate and international regulatory teams.
- Manage the planning and coordination of rollouts of product changes with corporate and international regulatory teams.
- Provide oversight and work with cross-functional management to review and approve rework of non-conforming product CAPA, SCAR, HHE and Field Actions. Support product risk management in accordance with FDA/ISO 14971.
- Manage the regulatory review of complex Change Engineering Requests, Document Change Requests, Variances, and other Quality System Documentation that requires regulatory review and approval to ensure compliance with government regulations.
- Manage and establish labeling requirements per regulations and review labeling that requires regulatory review and approval to ensure compliance with government regulations
- Provide leadership and mentoring to regulatory team by participating in career development programs and coaching RA team members about best practices of a RA professional using Integra values as a guide.
- Lead and participate in continuous improvement projects within Regulatory Affairs and throughout the organization.

**Qualifications**:

- Bachelor’s degree in Science, Engineering, Regulatory Affairs, or other technically related field.
- Minimum of 5-7 years related experience in an FDA regulated industry such as Medical Devices, Biotech or Pharma (must have at least 4 years in Regulatory Affairs and the remaining years can be in a related field such as Product Development, Quality, Operations to contribute to total experience). Education or certification in lieu of relevant experience accepted when the requirements below are met:

- RA Certification (RAC) can count towards 1 year of specific RA experience
- Master's degree can count towards 2 years of relevant (non-RA) experience
- Terminal degree (Doctorate or PhD in Business, Science, or related discipline) can count towards 4 years of relevant (non-RA) experience.
- Strong experience in working effectively with cross-functional teams and provide regulatory input (e.g., manufacturing sites, new product development teams, marketing teams, quality teams).
- Experience working with FDA locally and nationally.
- Expert applied knowledge of domestic and/or international medical device regulations including 510k and inte