Job description
Regulatory Affairs Manager – Medical DeviceOur client develops consumer friendly digital health solutions that improve health outcomes and prevent chronic disease for hundreds of millions of people world-wide. At the heart of these digital health solutions is their proprietary and patented biometric sensor technology, which enables medical-grade physiological monitoring via wearable devices in popular consumer form.
The Regulatory Affairs Manager is a vital member of the operations team working primarily with the company’s medical-grade monitoring wearable devices and digital health solutions. Wearable devices and solutions are newly designed products that the company is developing and will be subject to regulations for consumer and medical grade clearances. The Regulatory Affairs Manager will have the chance to help design and implement best practices in a fast paced and quickly growing startup company.
This is a hybrid full time position based in Raleigh, NC. No sponsorship or C2C arrangements are available.
Primary responsibilities of the Regulatory Affairs Manager:
- Work with engineering, manufacturing partners and suppliers to support development of new products and regulatory requirements. Support and implementation of required processes and controls to meet the needs of regulatory agencies like the FDA.
- Key member, contributor, and coordinator for the process, including documentation, that is required to submit for regulatory approvals like 510(k) submissions.
- Key member in the management and training of the quality management system, ensuring that it meets needs for obtaining medical clearance. As needed, manage risk and quality functions, document control, product change management, plus any additional processes that are required as the business expands.
- Support legacy businesses
- B.S. or higher in engineering or related discipline
- 2+ years’ experience in a regulatory role in a medical device company
- Experience working on documentation and 510(k) submissions to the FDA required
- Experience working with medical devices preferred
- SPC and Statistical analysis methods and tools
- Basic understanding of electrical and mechanical engineering, industrial design, and optics
- Exceptional communications skills: writing test plans, summarizing evaluation processes, summarizing complex discussions, and preparing reports for both internal and customer consumption
- Must be a self-starter and highly motivated individual that works well across multiple teams in the company.
- Experience working with electronics and optics
- Experience working with wearables or hearables or fitness brands
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Whether your current contract is coming to a close, you’re looking to advance your career or are a company on the hunt for new talent and wanting to expand…let HireNetworks put our networks to work for you.
HireNetworks is an equal opportunity employer.
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