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VP, Clinical & Regulatory Affairs Aesthetic Medical Device
Our client, an early-stage Medical Device start up operating in the Aesthetic / Wound Care market, is looking for a Vice President of Regulatory and Clinical Affairs. This position will report to the CEO and will be responsible for the overall regulatory and clinical affairs strategy and execution. The role will be a bit heavier on the Regulatory side, but solid clinical background is essential as well. The candidate will oversee development, implementation, and monitoring of all clinical development activities. Core responsibilities include clinical operations, regulatory affairs, quality assurance, and project management.
| Responsibilities: - Design and execute clinical trials to support the development and commercialization of the company’s technologies
- Ensure full compliance with all FDA and other regulatory bodies with respect to product submissions
- Develop solid clinical and regulatory strategies to ensure product approval success
- Direct all administrative activities associated with the department. This will include the establishment of goals and objectives, preparation and maintenance of operating and capital budgets, issuance of relevant operating procedures and the recruitment, training and assessment of key department personnel
- Provide regulatory monitoring to ensure patient safety and adequate reporting and coding of adverse events in clinical trials
- Periodically present regulatory and clinical affairs updates to the Management team and the Board of Directors
- Support the product development team with regulatory input on next generation products
- Create a positive working relationship with all groups within FDA
- Position responsibilities will include, but not limited to;
- Lead and facilitate investigator/site recruitment and interaction.
- Provide leadership and team building for the development and execution of clinical/regulatory plan(s), and provide clinical/regulatory intelligence and expertise in translating regulatory requirements into practical workable plans.
- Participate in the design and review of clinical trial protocols, as well as report drafting and writing. Review study reports and prepare any manuscript/presentations associated with them.
- Manage external partnerships including consultants and CRO’s.
- Ensure compliance with FDA regulations and Good Clinical Practice (GCP) guidelines and SOP’s for clinical studies.
| Requirements: - Extensive experience (a minimum of 10 years experience) in direct management of regulatory and clinical affairs for medical devices (Class II/III)
- BS/BA minimum (prefer masters degree)
- Demonstrated success in development of clinical and regulatory strategies, through all phases of deployment such as protocol development, site selection, and trial execution
- Successful management of a major U.S, multi-center, prospective pivotal clinical trial
- Proven leadership in compliance with respect to FDA regulations and guidelines related to clinical strategy, GCPs, GLPs, SOPs, submissions, product launch, labeling, advertising and promotion, and medical device reporting
- Demonstrated success in building and managing Regulatory and Clinical Affairs departments
- Ability to function in a small company, "hands-on" environment
- Strong written, verbal and presentation skills, including the ability to present, persuade and convince regulators, investors and key opinions leaders with respect to the company's products and clinical/regulatory strategies
- Advanced knowledge of regulatory requirements for PMAs, 510K’s, Annual Reports and promotional materials
- Strong working knowledge of medical procedures, drug therapies, statistical concepts and data collection, reporting and computerization of data collected in clinical trials.
- Must have the capability to discuss statistical aspects of studies with investigators, medical directors, and regulatory authorities, and possess skills and knowledge for project planning/management/control, budget management, etc.
- Experience working with consultants and CRO’s, as part of a virtual team.
- Experience participating in the design of clinical trial protocols and CRF’s.
- Ability to review, understand and explain the appropriate FDA guidance documents to guide the project team is required.
- Self-starter.
- Ability to operate in a small company dynamic.
- Ability to drive meetings with various stakeholders:
(i) senior management
(ii) the FDA
(iii) investors
(iv) expert advisors - Excellent attention to detail.
- Passion, energy, personal drive and motivation.
- Outstanding written, oral, organizational, and interpersonal skills are required.
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