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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

regulatory submission documents510(k)EU MDR Technical DocumentationSaMD submissionsSiMD submissionsFDA QSRISO 13485ISO 14971IEC 62304software development life cycle

Soft Skills

collaborationstrategic guidancecross-functional teamworkleadership

Certifications

RAPS certification