Sr. Regulatory Affairs Specialist
Siemens Healthineers
Summary
The Senior Regulatory Affairs Specialist is a senior individual contributor on the RA Submissions Team who partners closely with cross-functional teams to develop and execute regulatory strategies for Radiation Oncology products. The role requires strong regulatory judgment, comfort navigating ambiguity, and the ability to translate evolving global regulatory requirements into clear, actionable guidance.
Job description
Your Role on the RA Submissions Team
- Lead cross-functional regulatory discussions, align stakeholders on submission strategy, and communicate regulatory implications to support business and product development decisions.
- Lead preparation and execution of regulatory submissions, including strategy development, content planning, timeline alignment, and coordination of cross-functional inputs.
- Identify regulatory risks, evaluate pathway options, and develop clear recommendations that support product development, change assessments, and market authorization decisions.
- Support interactions with regulatory agencies and regional partners by preparing briefing materials, submission responses, and clear positions on regulatory questions.
- Help enable timely global market access for radiation oncology products by translating complex technical information into defensible regulatory submissions and strategies.
Required Qualifications
- Bachelor’s degree in engineering, scientific, clinical, or regulatory discipline with 7+ years of related regulatory affairs experience, or equivalent education and experience.
- Non-technical degrees with equivalent complex medical device experience are acceptable.
- Demonstrated experience as the primary regulatory author or submission lead for medical device applications, including FDA 510(k), IDE, Q-submissions, Health Canada Medical Device License applications, and EU MDR technical documentation/CE marking.
- Strong ability to interpret regulations, identify data needs, resolve regulatory issues, and collaborate effectively with technical and cross-functional partners.
- Ability to work independently, communicate clearly, and manage competing priorities in a fast-paced, ambiguous environment.
- Ability to travel less than 20%, based on project and business needs.
Preferred Qualifications
- Advanced degree or equivalent depth of technical regulatory experience in a scientific, clinical, engineering, or regulatory discipline.
- Experience leading global regulatory strategy and submissions for radiation oncology systems, complex software-driven devices, or other highly technical medical technologies.
- Strong working knowledge of global medical device requirements and standards, including FDA, Health Canada, EU MDR, ISO 13485, ISO 14971, IEC 62304, IEC 62366, and applicable electrical safety standards.
- Demonstrated ability to influence stakeholders, advise leadership, respond to regulatory authority questions, and translate complex technical information into clear regulatory positions.
- RAC certification or demonstrated commitment to continued regulatory professional development.
Requirements
- Bachelor’s degree in engineering, scientific, clinical, or regulatory discipline
- 7+ years of related regulatory affairs experience
- Demonstrated experience as primary regulatory author or submission lead for medical device applications
- Experience with FDA 510(k), IDE, Q-submissions, Health Canada Medical Device License applications, and EU MDR technical documentation/CE marking
- Strong ability to interpret regulations, identify data needs, resolve regulatory issues, and collaborate effectively
- Ability to work independently, communicate clearly, and manage competing priorities
- Ability to travel less than 20%
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k) retirement plan
- Life insurance
- Long-term disability insurance
- Short-term disability insurance
- Paid parking
- Public transportation
- Paid time off
- Paid sick and safe time
Company overview
Siemens Healthineers is a German multinational medical technology company specializing in diagnostic and therapeutic imaging, laboratory diagnostics, and molecular medicine. Founded in 2017 as a spin-off from Siemens AG, the company has established itself as a global leader in healthcare technology with a comprehensive portfolio that addresses the complete care continuum for many of the world's most threatening diseases. With approximately 69,500 employees worldwide and operations in over 70 countries, Siemens Healthineers generates annual revenues exceeding €21 billion. The company's product offerings span across four main business segments: Imaging (including CT, MRI, ultrasound, and X-ray systems), Diagnostics (laboratory and point-of-care testing), Varian (cancer care and radiation therapy), and Advanced Therapies. Siemens Healthineers is particularly renowned for pioneering breakthroughs in medical imaging, having developed the world's first commercial PET/CT scanner and continuing to innovate in areas such as artificial intelligence, digital health solutions, and precision therapy. The company's commitment to research and development, with annual investments of approximately €1.5 billion, drives its mission to pioneer breakthroughs in healthcare for everyone, everywhere, sustainably.