Director of Regulatory Operations
This position is responsible for providing regulatory direction and strategy based on medical device regulatory requirements in both US and Rest of World (ROW). In addition, they are responsible for the preparation, management, and review of simple and complex regulatory submissions based on an established regulatory strategy. They also serve as a liaison between regulatory and other functional areas including external partners, clients and consultants in the planning, organizing, and preparing of regulatory documents following project, corporate and industry regulatory strategies.
ESSENTIAL DUTIES AND RESPONSIBLITIES
- Responsible for developing, writing and implementing regulatory strategy for assigned projects.
- Provides advice and support to project teams for regulatory operations aspects of projects ensuring adherence and compliance. Actively drives interactions with regulatory bodies as assigned
- Provides regulatory support for EU Technical Files conforming to EU MDR
- Assesses regulatory files to determine conformance to applicable regulatory requirements. Provides guidance to project teams on addressing any compliance issues or risks.
- Prepares, coordinates, manages simple and complex regulatory submissions for medical device in accordance with applicable regulations.
- Translates regulatory requirements into practical, workable submission plans; develops & maintains timelines; coordinates internal/external authoring/review/comment adjudication and finalization (submission and archival).
- Provides regulatory expertise in comments during document review, mindful of regulatory requirements pertaining to document content.
- Interfaces with internal and external functional groups in the preparation, review, compilation, finalization submission and posting of regulatory submissions.
- Acts as liaison between regulatory and other functional areas; represents regulatory in cross-functional team meetings.
- Identifies and initiates process improvements which have an impact on regulatory affairs, quality assurance or other departments.
- Reviews and communicates current and emerging regulatory requirements (e.g., US and international regulations and guidelines).
- Authors and reviews standard operating procedures (SOPs); ensures SOPs are compliant with current regulatory requirements and provides regulatory support for corporate quality assurance efforts.
- Develops, maintains and applies current regulatory knowledge to applicable responsibilities.
OTHER DUTIES AND RESPONSIBILITIES
- Provides expertise in the pharmaceutical and medical device approval process ensuring corporate compliance.
- Maintains and increases job knowledge by studying the state-of-the-art, ongoing research in the field, etc.; participates in educational opportunities; reads professional publications; maintains personal networks; participates in professional organizations, as needed.
Note that this position description is not designed to cover or contain a comprehensive listing of all activities, duties or responsibilities that are required in the performance of this job. Duties, responsibilities and activities may change at any time with or without notice.
MINIMUM EDUCATION, SKILLS AND EXPERIENCE REQUIRED
BA/BS degree in health or science related discipline. Five to ten years of professional experience in submitting medical device products for regulatory approval. Experience in regulatory strategies, product development, GMP, and regulatory submissions and registrations including but not limited to FDA and EU.
Extensive experience in medical device regulations include the US and EU regulatory requirements. Experience with medical device standards and guidance’s such as ISO 14971, ISO 14155, IEC 62304, EN 62366, etc., a plus.
Experience with clinical investigation, a plus.
Demonstrated experience as a self-starter and a fast learner; must work efficiently, both independently and within a team; must have very good problem-solving skills and attention to details. Excellent written and verbal communication skills are required and must be able to write clear reports, papers, proposals, etc., and efficiently discuss the same with other scientists, engineers, and customers. Must be proficient in project management; be extremely flexible and able to work in a fast-paced environment. Must also be able to interact with a diverse group of colleagues both internally and externally in a professional and collaborative manner. Independent judgment is required to plan, prioritize and organize diversified workload.