Sr. Clinical Affairs Specialist

About the role

The Senior Clinical Affairs Specialist provides advanced clinical and technical expertise to support clinical affairs activities for both marketed and new medical devices. The role involves crafting, reviewing, and updating clinical documents, collaborating with Medical and Regulatory Affairs, and mentoring junior team members.

Key responsibilities

• Lead the preparation, review, and maintenance of clinical and technical documentation such as Clinical Evaluation Reports, PMCF plans, and SSCPs.
• Ensure all clinical documentation complies with EU MDR, ISO 14155, GCP, MEDDEV guidance, and internal procedures.
• Provide clinical and technical support for regulatory submissions, product registrations, certifications, and authority responses.
• Support planning, execution, and oversight of clinical investigations, including study documentation and Ethics Committee submissions.
• Review clinical study documents, literature evaluations, and data analyses to ensure scientific validity.
• Monitor clinical data quality, identify compliance issues, and support audit activities.
• Act as the Clinical Affairs subject‑matter expert for Regulatory Affairs, R&D, Post‑Market Surveillance, Quality Assurance, Medical Affairs, and Commercial teams.
• Contribute clinical input to risk management activities and align evidence with product safety requirements.
• Mentor junior Clinical Affairs staff and drive professional development.
• Identify process improvement opportunities and enhance Clinical Affairs procedures and systems.

Required profile

• Bachelor's degree in Health Sciences, Life Sciences, Nursing, Pharmacy, Medicine, Biomedical Engineering, or a related field.
• Minimum 5 years of experience in clinical investigation or regulatory affairs within the medical device industry.
• Strong knowledge of international medical device regulations and standards, including GCP and ISO 14155.
• Experience conducting systematic literature reviews and evaluating clinical data.
• Understanding of risk management principles applied to medical device development.
• Excellent written and verbal communication skills in Spanish and English (intermediate to advanced English required).
• Willingness to travel as needed.
• Valid U.S. visa and Yellow Fever vaccination are desirable but not mandatory.

Required skills

• Microsoft Office Suite
• Word
• Excel
• PowerPoint