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The Clinical Affairs Specialist will be responsible for supporting clinical compliance throughout the product lifecycle, with a focus on ensuring conformance to EU MDR 2017/745, FDA, and China NMPA clinical requirements. This role involves planning, executing, and maintaining key Clinical Lifecycle Management documentation, including Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-up (PMCF) Plans and Evaluation reports, and clinical data assessments to support product submissions, renewals, and global market access.

Key Responsibilities:

Prepare and maintain Clinical Evaluation Reports (CERs) in accordance with EU MDR 2017/745, MEDDEV 2.7/1 Rev. 4, and MDCG guidance.

Develop and manage PMCF Plans and PMCF Evaluation Reports, incorporating real-world evidence and post-market data.

Support global regulatory submissions by contributing clinical content in accordance with FDA and China NMPA requirements.

Collaborate with regulatory, R&D, quality, and marketing teams to support product submissions and life-cycle management.

Assist in the planning, execution, and reporting of clinical investigations as needed.

Support clinical lifecycle management from pre-market strategy through post-market surveillance.

Conduct regulatory assessments of upcoming R&D collaboration projects with key customer sites.

Monitor evolving global clinical requirements and standards, ensuring company compliance with applicable guidance (e.g., ISO 14155, MDCG guidelines)

Manages the preparation of clinical and pre-clinical portions of regulatory submissions.

Coordinates the communication with regulatory authorities and Ethics Committees for the application for clinical studies.

Required Skills & Qualifications:

Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, or a related field

Minimum of 3–5 years of experience in Clinical or Regulatory Affairs within the medical device industry, preferably with medical imaging technologies

Strong knowledge of EU MDR 2017/745 clinical requirements, including CERs and PMCF activities

Familiarity with FDA clinical study and evaluation requirements (e.g., 21 CFR 812) and China NMPA clinical expectations

Detail-oriented with strong project management and organizational skills

Comfortable working in cross-functional teams

Who we are: We are a team of more than 73,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

To find out more about Siemens Healthineers businesses, please visit our company page here.

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