Clinical Affairs Specialist

To support global clinical strategies, the full-time Clinical Affairs Specialist III will manage clinical data integrity, represent the Clinical Affairs function on product development teams, and ensure compliance with regulatory requirements while working remotely. Key responsibilities Contribute to clinical evidence requirements for product submissions and post-submission activities Generate interim and final reports while ensuring adequate monitoring of all clinical trials Interface with regulatory bodies to facilitate approvals and provide clinical perspectives on field complaint investigations Required qualifications Degree in Science, Engineering, Health Science, Nursing, or a related field 3 years of professional experience in the medical device or pharmaceutical industry, or 5-7 years without a degree Experience with US and international medical device regulatory submissions/approvals Knowledge of clinical evaluations and various medical device regulations Proficiency in ERP systems and data analysis tools like Minitab and Excel