Senior manager regulatory affairs
Location
Cambridge, MA | United States
Job description
The Senior Manager, Regulatory Affairs - Devices manages, evaluates and completes regulatory projects consistent with the company goals. Responsible for timely planning and coordination of regulatory submissions. Provides guidance to cross-functional teams on regulatory strategy and tactics. Keeps abreast of regulatory procedures and practices. The incumbent will work independently with appropriate oversight and is expected to identify and act on activities without requiring immediate direction.
- With minimal supervision, plan and manage regulatory activities related to assigned development projects for medical devices. Assist in developing and implementing strategies for the earliest possible approvals of regulatory submissions associated with assigned development projects.
- Manage the assembly and timely submission of device applications (i.e., 510, PMA, De Novo, IDE) as required for investigation and commercialization of devices.
- Ensure regulatory submissions are maintained in compliance with regulatory requirements.
- Represent the company in its dealings with the FDA and other regulatory authorities, as appropriate.
- Participate on project teams and provide expertise on regulatory matters related to medical devices.
- Develop and maintain current regulatory knowledge and advise management of significant developments.
- Contribute to internal improvements related to medical device best practices and SOPs.
- Perform other duties as required, interfacing with other departments, CROs, and external vendors as needed.
Education
- Bachelor of Science in a scientific discipline.
- Master of Science (preferred)
Basic Qualifications - 3+ years direct Regulatory Affairs experience in the US market with medical devices (class I, II and III). Previous experience with combination products and humanitarian devices a plus.
- Experience and knowledge in preparation of device submissions and supportive amendments and supplements.
- Experience with device advertising and promotional review committee’s
- Experience with labeling and UDI regulations
- Working knowledge of FDA regulations and understanding of FDA structure and function.
- Working knowledge of device submission elements and structure.
- Strong regulatory writing skills and use of Microsoft Word.
- Strong team player that has a customer service approach and is solution oriented.
- Attention to detail and the ability to work individually, within a multidisciplinary team, or with external partners and vendors.
- Possess excellent written and verbal communication skills.
About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email
[email protected] for other accommodation options.
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