Compliance Manager overseeing United Rotorcraft’s compliance initiatives with federal standards. Ensuring audit readiness and managing supplier compliance and training programs.
About the role
- Senior Regulatory Affairs Specialist in Ultrasound focusing on regulatory submissions and product clearances. Collaborating with regulatory authorities to ensure compliance and timely product development.
Responsibilities
- Collaborating with regulatory teams and authorities to secure timely product clearances
- Coordinating and preparing regulatory submission documents for agencies such as the FDA, Health Canada, EU Competent Authorities, NMPA, and ANVISA
- Offering strategic guidance on clinical studies and evaluations
- Serving as the Regulatory Affairs representative for BG Ultrasound
- Providing guidance on regulatory issues related to product development, labeling, and marketing strategies
- Supporting cross-functional teams with regulatory expertise during the design and development phases for new products
- Leading global regulatory intelligence initiatives and contributing to regulatory and product registration strategies
Requirements
- 5+ years of experience in medical device regulatory affairs
- 510(k), and EU MDR Technical Documentation authoring experience required
- Experience with SaMD or SiMD submissions is strongly preferred
- Strong understanding of relevant regulations and standards (FDA QSR, ISO 13485, ISO 14971, IEC 62304)
- Experience with software development life cycle, artificial intelligence, data science, and/or software testing is preferred
- Bachelor’s/Master’s Degree in a science, engineering, or health-related discipline
- RAPS certification is a plus
- Must be able to successfully perform the minimum Physical, Cognitive and Environmental job requirements with or without accommodation.
- Willing and able to travel up to 10% based on business needs.
Benefits
- generous PTO
- 401k (up to 7% match)
- HSA (with company contribution)
- stock purchase plan
- education reimbursement
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