Regulatory Affairs Professional

Join us in pioneering breakthroughs in healthcare. This hybrid role is based in Walpole, MA.

• Prepare, submit, and maintain regulatory submissions and lifecycle documentation, including FDA PMA Annual Reports, PMA 30‑day notices and supplements, 510(k) submissions and notes to file, IVDR Class D recertifications, significant change notifications, and other regulatory applications as required.
• Serve as a Regulatory Affairs subject matter expert, providing guidance to design control activities and new product development teams.
• Prepare, submit, and maintain Technical Files in compliance with applicable regulatory requirements and the Quality Management System (QMS).
• Collaborate with cross‑functional teams to develop and maintain quality guidelines, procedures, and work instructions that support ongoing regulatory compliance.
• Independently or collaboratively lead and contribute to regulatory projects, ensuring timely execution and alignment with regulatory strategy.
• Provide training to internal stakeholders on country‑specific regulatory requirements, as applicable.
• Review promotional and labeling materials for regulatory compliance in accordance with country‑specific requirements.
• Ensure audit‑ and inspection‑ready documentation and provide guidance to cross‑functional teams on appropriate regulatory documentation practices.
• Participate in internal and external audits, including quality system audits, design dossier reviews, regulatory authority inspections, and DEA audits, as applicable.

• Bachelor’s degree in a scientific discipline.
• Minimum of 2 years of experience in IVDs or medical devices.
• Working knowledge of US/EU regulations and standards applicable to medical device market clearance.
• Knowledge of IVD products and applicable regulations for such products.
• Strong presentation, team orientation, communication skills, and cross‑functional collaboration.
• Excellent attention to detail, strong organizational skills, ability to multi‑task and work effectively in a dynamic environment.
• Skilled in Outlook, SharePoint, Adobe Acrobat, Microsoft Office applications, including Excel and Azure Dev Ops.
• Experience working in a GMP environment.
• Intercultural sensitivity.

$123,120 - $169,290 (May vary by geography, skills, experience, and other qualifications).

• Medical insurance
• Dental insurance
• Vision insurance
• 401(k) retirement plan
• Life insurance
• Long‑term and short‑term disability insurance
• Paid parking/public transportation
• Paid time off, paid sick and safe time

Siemens Healthineers is an Equal Opportunity and affirmative action employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, disability, veteran or military status, or any other category protected by federal, state, or local law. Applicants and employees are protected under Federal law from discrimination.