Siemens Healthcare Hiring Senior Regulatory Affairs Specialist

Siemens Healthcare is constantly innovating its portfolio of products and services in its core areas of diagnostic imaging, Advanced Therapy, Diagnostic which includes Point of Care, Ultra Sound and many more. Siemens Healthineers is also actively developing its digital health services and enterprise services to help customers succeed in today's dynamic healthcare marketplace, Siemens healthineers is championing new business models that maximize opportunity and minimize risk for healthcare providers.

Post : Sr. Regulatory Affairs Specialist

Job Description
• 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.

Candidate Profile
• 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 That Will Set You Apart
You will stand out if you bring regulatory strategy experience, technical depth in complex medical technologies, and the ability to influence stakeholders through clear, defensible regulatory positions.
• 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.

Additional Information
Experience : 7+ years
Qualification : Bachelor’s degree
Location : Hybrid
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 25th October 2026