Regulatory Affairs Professional

Siemens Healthineers

9d•$123,120 - $169,290•Hybrid

About The Position

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. This is a role well suited to an ambitious professional, looking for the next step in their career. This is a hybrid role based in Walpole, MA.

Requirements

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
Very good presentation skills, and you show team orientation and communication skills.
Ensure cross-functional collaboration and cooperation.
Excellent attention to details.
Able to multi-task and work effectively in a dynamic environment.
Bachelor’s degree in scientific discipline
Minimum of 2 years of experience in IVDs or Medical devices
Skilled in Outlook, SharePoint, Adobe Acrobat, and Microsoft Office applications, including Excel and Azure DevOps
Experience of working in a GMP environment
Intercultural sensitivity
Strong attention to detail and excellent organizational skills

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.