Regulatory Affairs Director
About The Position
Develops and implements global Regulatory strategies for Class III medical devices This individual will be the Regulatory subject matter expert for all applicable medical devices. S/he will need to identify, assess and communicate regulatory development and submission strategies, regulatory risks, interface with relevant regulatory authorities and create all regulatory submissions. S/he will develop strategies for regulatory approval, for both US and OUS clinical and pre-clinical trials and will provide regulatory guidance to Clinical Affairs, Quality Systems, Manufacturing and Development. S/he will be responsible for preparing submissions, obtain and maintain their approval while ensuring all activities are carried out in compliance with all applicable laws and regulations. The ideal candidate should be experienced in exercising independent judgment in determining appropriate regulatory actions and requirements for early feasibility and first-in-human studies. S/he will have a strong technical and analytical background with a thorough knowledge of medical device regulations. S/he will be “hands-on”, able to function in a start-up like environment, and successful in partnering with senior teams on strategy and execution.
Requirements
- Bachelor’s degree and 10+ years of experience in the medical device industry, Class III required
- Proven track record of regulatory approvals including clinical trials, early feasibility or first-in-human studies preferred
- Must be able to manage multiple and competing priorities and manage programs with minimal oversight.
- Experienced leading design assurance activities for new product development.
- Strong written and verbal communication skills
- Critical Thinker, highly organized, efficient and self-motivated
- Excellent interpersonal, communication, and negotiating skills.
- Experience with SaMD and Digital Health apps
- Demonstrated Microsoft Word, Excel, Office, PowerPoint, and Adobe software skills
Responsibilities
- Develop and implement regulatory strategies and plans for early feasibility and first-in-human studies
- Prepare and submit regulatory submissions to US and international regulatory agencies
- Coordinate and communicate with internal and external stakeholders, such as project teams, quality assurance, clinical research, manufacturing, marketing, research and development, and legal
- Review and approve product labeling, advertising, and promotion for compliance with regulatory requirements
- Monitor and analyze changes in regulatory environment and assess the impact on current and future products
- Maintain and update regulatory databases, files, and documentation
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What This Job Offers
Job Type
Full-time
Career Level
Director
