Senior Regulatory Affairs Specialist

Philips • Bothell, WA

23h • Onsite

About The Position

Senior Regulatory Affairs Specialist, Ultrasound The Senior Regulatory Affairs Specialist for Ultrasound collaborates with regulatory teams and authorities to secure timely product clearances. Responsibilities include coordinating and preparing regulatory submission documents for agencies such as the FDA, Health Canada, EU Competent Authorities, NMPA, and ANVISA, and offering strategic guidance on clinical studies and evaluations. Your role: Act as an ambassador of Philips values and ensure compliance with all relevant business processes and regulatory procedures. Serve as the Regulatory Affairs representative for BG Ultrasound, providing guidance on regulatory issues related to product development, labeling, and marketing strategies. Coordinate and prepare documentation for regulatory submissions—such as Product Reports, Technical Files, Declarations of Conformity, and Medical Device Licenses—for various global markets. Support 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. You're the right fit if: You’ve acquired 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. You have 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. You have a Bachelor’s/Master’s Degree in a science, engineering, or health-related discipline. RAPS certification is a plus. You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position . You’re an excellent communicator, with an ability to influence cross-functional stakeholders utilizing your regulatory expertise. You are willing and able to travel up to 10% based on business needs. How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is an office-based role. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others. Learn more about our business . Discover our rich and exciting history. Learn more about our purpose. Learn more about our culture.

Requirements

• 5+ years of experience in medical device regulatory affairs, with 510(k), and EU MDR Technical Documentation authoring experience required.
• 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.
• Bachelor’s/Master’s Degree in a science, engineering, or health-related discipline.
• 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.
• US work authorization is a precondition of employment.
• For this position, you must reside in or within commuting distance to one of the posted locations.

Nice To Haves

• Experience with SaMD or SiMD submissions is strongly preferred.
• International submissions experience is a plus.
• Experience with software development life cycle, artificial intelligence, data science, and/or software testing is preferred.
• RAPS certification is a plus.

Responsibilities

• Collaborate with regulatory teams and authorities to secure timely product clearances.
• Coordinate 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 an ambassador of Philips values and ensure compliance with all relevant business processes and regulatory procedures.
• Serve as the Regulatory Affairs representative for BG Ultrasound, providing guidance on regulatory issues related to product development, labeling, and marketing strategies.
• Coordinate and prepare documentation for regulatory submissions—such as Product Reports, Technical Files, Declarations of Conformity, and Medical Device Licenses—for various global markets.
• Support 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.

Benefits

• Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees