Clinical Affairs Specialist

Job Summary

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