Director of Regulatory Affairs
This role will serve as the regulatory subject matter expert for our business by taking a hands-on role in defining, deploying, and leading regulatory and compliance strategies.
- Craft, implement and maintain a Company-wide medical device regulatory affairs system.
- Provide expertise and guidance in interpreting regulations, agency guidelines, and internal/corporate policies to ensure compliance is maintained and results are achieved.
- Develop regulatory strategies for operational improvements and analyzes risk vs. benefit in regulatory strategies to ensure successful review by regulatory agencies.
- Oversee the development and implementation of company and departmental SOP’s.
- Ensure compliance with applicable FDA, GMP, ISO, protocols and regulations.
- Evaluates manufacturing changes for regulatory impact and to ensure compliance.
- Define ownership, roles, and responsibilities for specific individuals and teams.
- Prioritize resources for initiatives as directed by regulatory affairs with appropriate management of compliance needs, timing and budget.
- Develop and maintain compliance training programs.
- Establish metrics for evaluating the quality and timelines of submissions.
- Ensure department compliance with company policies and procedures.
- Manage the preparation of registration packages.
- Manage submission data requirements and deliverable dates with regulatory bodies.
- Partner with Quality as key contacts for regulatory body interactions including preparation of submissions and strategy for meetings, inspections, and agency responses.
- Maintain awareness of regulatory legislation and assess its business impact.
- Oversee review and revision of Regulatory Affairs documents.
- Provide direction and successful attainment of CE Mark.
- A minimum of 8 years regulatory affairs experience in the medical device, pharmaceutical, and/or medical diagnostics industry.
- Be a results-oriented leader with excellent collaboration and project management skills.
- Possess solid decision-making capabilities with strong expertise of regulatory compliance requirements.
- CE Mark experience is highly desirable.