Durham, NC 27709
Vice President Regulatory Affairs
Baebies – guided by the vision that “everyone deserves a healthy start” – develops and commercializes products and services that enable early disease detection and comprehensive diagnosis for children. Baebies’ products include SEEKER®, an FDA-cleared and CE-marked high throughput newborn screening platform, and FINDERTM, a low volume pediatric testing platform currently under development. Our mission is to save lives and make lives better for all children by bringing new technologies, new tests and new hope to parents and healthcare professionals worldwide.
The VP of Regulatory Affairs (RA) is responsible is responsible for conducting strategic regulatory planning for delivery of new and revised product introductions into US and international markets. The position is responsible for the life cycle management of existing products from a regulatory perspective.
The VP Regulatory Affairs is the liaison between the Company and Regulatory Authorities and has responsibility for establishing, developing and maintaining relationships and communications with Regulatory Authorities, internal business management and external business affiliates. VP of Regulatory Affairs will direct and manage a team of regulatory professionals.
Roles and Responsibilities
a. Proactively develop, lead, and drive the execution of regulatory and clinical strategy with a focus on efficient, rapid and timely market approval
b. Oversee development and negotiation of regulatory plans regarding safety, efficacy, and quality to assure viability for global or regional registrations.
c. Manage, schedule and coordinate communications with regulatory authorities on behalf of the company. Oversee the preparation and filing of all regulatory applications with FDA and global regulatory authorities. Develop, communicate and maintain project schedules for regulatory filings that are consistent with product development and commercialization plans. Accountable for ensuring that regulatory submissions meet appropriate standards and content requirements. Identify risk areas and develop alternative courses of action including anticipation of regulators’ responses through alternative scenario planning and development of contingency plans.
d. Work with marketing to gain an understanding of customer/user requirements and expectations. Translate marketing requirements into labeling
e. Direct the development of systems, practices, and processes to ensure efficient and effective clinical trials including clinical trial management, data analysis, final study report, and publications while ensuring all clinical studies are executed to the highest ethical and safety standards. Collaborate effectively with business leadership, product development and marketing. Manage third party relationships and contracts for clinical research organizations and services.
Education, Experience, Qualifications and Requirements
- Education – BA/BS in engineering, life science, or regulatory affairs.
- Regulatory certification required.
- 10 plus years of experience in the medical devices regulatory affairs, including in vitro diagnostics experience.
- Proven capabilities in the field of regulatory strategy and market clearance/approval of original, novel or advanced technologies
- Expert knowledge of medical device regulations, standards, current industry practices, and strong experience with interpretation and application. Experience with hardware/software medical devices required.
- Experience in strategic planning, risk management and problem solving and collaboration with key operational groups.
- High level of personal and professional integrity and the ability to work independently with minimal direction.
- Highly adaptable and able to excel in fast paced environment.
- Ability to develop and manage a high performance team focused on accountability and meeting and exceeding expectations.
- Excellent written and verbal communication, presentation, and facilitation skills.
- Strong negotiation skills and significant experience in interacting with regulatory authorities.
To apply, please send an email with with your resume and POS ID 10094 in the subject line. Please do not stop by our office or call to inquire about this position. You will be contacted by phone or email if the hiring managers wishes to set up an interview. Thank you.