Senior Regulatory Affairs Specialist

About the role

The Senior Regulatory Affairs Specialist for Ultrasound collaborates with regulatory teams and authorities to secure timely product clearances.

Responsibilities

• Coincide and prepare regulatory submission documents for agencies such as the FDA, Health Canada, EU Competent Authorities, NMPA, and ANVISA.
• Offer strategic guidance on clinical studies and evaluations.
• Act as the Regulatory Affairs representative for BG Ultrasound, providing guidance on regulatory issues related to product development, labeling, and marketing strategies.
• Cook up and prepare documentation for regulatory submissions—such as Product Reports, Technical Files, Declarations of Conformity, and Medical Device Licenses—for various global markets.
• Cross-functional teams with regulatory expertise during the design and development phases for new products and major changes to existing products.
• Lead global regulatory intelligence initiatives, contribute to regulatory and product registration strategies, and help implement global regulatory roadmaps based on the competitive landscape and marketing objectives.

Requirements

• 5+ years of experience in medical device regulatory affairs, with 510(k), and EU MDR Technical Documentation authoring experience required.
• Experience with SaMD or SiMD submissions is strongly preferred.
• International submissions experience is a plus.
• Strong understanding of relevant regulations and standards (FDA QSR, ISO 13485, ISO 14971, IEC 62304, and other applicable regulations and standards related to software medical devices is preferred).
• Experience with software development life cycle, artificial intelligence, data science, and/or software testing is preferred.
• A Bachelor’s/Master’s Degree in a science, engineering, or health-related discipline.
• RAPS certification is a plus.

Qualifications

• Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
• An excellent communicator, with an ability to influence cross-functional stakeholders utilizing your regulatory expertise.
• Willing and able to travel up to 10% based on business needs.