Regulatory Affairs Professional

Regulatory Affairs Professional Hybrid role based in Walpole, MA. Responsibilities 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. Independently or as part of a team, 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. Qualifications Solid working knowledge and experience of the US/EU regulations and standards applicable to medical device market clearance. Knowledge of IVD products and applicable regulations for such products. Excellent presentation skills, team orientation, and communication skills. Strong cross‑functional collaboration and cooperation. Excellent attention to detail. Ability to multi‑task and work effectively in a dynamic environment. Required Skills Bachelor’s degree in a scientific discipline. Minimum of 2 years of experience in IVDs or Medical devices. Proficiency in Outlook, SharePoint, Adobe Acrobat, and Microsoft Office applications, including Excel and Azure DevOps. Experience working in a GMP environment. Intercultural sensitivity. Strong attention to detail and excellent organizational skills. The base pay range for this position is: $147,760 - $203,170. Benefits 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 Equal Employment Opportunity Statement 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, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender status, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law. EEO is the Law Applicants and employees are protected under Federal law from discrimination. To learn more, Siemens Healthineers encourages participation in the company’s equal opportunity programs. Reasonable Accommodations Siemens Healthineers is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations. #J-18808-Ljbffr Dormont Manufacturing Co