Clinical Affairs Specialist

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Clinical Affairs Specialist based in the United States. This role sits at the intersection of clinical expertise, regulatory science, and medical innovation, supporting the development of advanced solutions in radiation oncology. You will work closely with regulatory leadership to shape clinical strategies, ensure compliance, and contribute to the safe and effective use of technologies that improve cancer care. The position offers exposure to both hands‑on clinical evaluation work and strategic regulatory submissions within a fast‑evolving healthcare technology environment. You will play a key role in preparing clinical documentation, supporting global market access, and strengthening post‑market surveillance activities. This is an opportunity to contribute meaningfully to patient safety while collaborating with multidisciplinary teams across clinical, regulatory, and engineering functions. The environment is mission‑driven, highly collaborative, and focused on continuous improvement and innovation in healthcare delivery. Accountabilities In this role, you will support clinical and regulatory activities across the product lifecycle, ensuring scientific rigor, compliance, and high‑quality documentation. You will collaborate closely with regulatory leadership to advance clinical affairs processes and support both new and marketed products. Key responsibilities include: Supporting the preparation of regulatory submissions, clinical evaluations, and impact assessments Conducting clinical evaluation plans (CEPs), clinical evaluation reports (CERs), and annual updates Performing literature searches, systematic reviews, and evidence synthesis aligned with regulatory standards Supporting global regulatory interactions and contributing to market access and compliance activities Ensuring adherence to Quality Management Systems and ISO 13485 requirements Assisting with post‑market surveillance reporting and documentation of compliance with regulatory standards (including GSPR) Reviewing technical data, clinical documentation, and study outputs for accuracy and completeness Coordinating clinical documentation workflows across cross‑functional teams and maintaining regulatory records Requirements This position requires a strong clinical background in radiation oncology combined with an interest in clinical affairs, regulatory documentation, and evidence‑based medicine. You should be highly analytical, detail‑oriented, and comfortable working with scientific literature and technical documentation. Key qualifications include: 3+ years of clinical experience in radiation oncology (e.g., medical physicist, dosimetrist, or related role) Strong ability to research scientific journals and evaluate clinical evidence in external beam radiation oncology Experience writing structured clinical or research reports with independent analysis Familiarity with clinical evaluation processes, test protocols, or regulatory documentation Strong communication skills with the ability to explain complex clinical or regulatory concepts clearly High motivation, intellectual curiosity, and ability to work independently in a fast‑paced environment Strong organizational skills with the ability to manage multiple priorities and meet deadlines Preferred: prior clinical affairs experience, including CER/CEP development and ISO 13485 exposure Preferred: familiarity with EU‑MDR submissions and PRISMA methodology Benefits Competitive base salary ($120,000–$190,000 depending on experience and level) Health, dental, and vision insurance with coverage starting on day one Short‑term and long‑term disability coverage and life insurance options 401(k) retirement plan with employer match Generous paid time off, paid holidays, and flexible work arrangements Monthly internet stipend and home office equipment support Professional development support, including certifications, memberships, and conference attendance Fully remote work environment with occasional virtual events and company retreats Additional benefits aligned with local regulations for international team members (where applicable) #J-18808-Ljbffr Jobgether