Associate Specialist, Clinical Compliance

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Associate Specialist, Clinical Compliance position is a unique career opportunity that could be your next step towards an exciting future.
 

How you’ll make an impact:

• Collaborate with clinical teams to maintain compliance and address non-compliance issues.
• Manage the learning management system, training plans, and study rosters; identify and resolve training gaps.
• Conduct compliance assessments and recommend solutions for low-impact regulatory and procedural gaps.
• Support internal and external audits, including preparation, team coordination, and follow-up.
• Partner with Clinical Affairs teams to resolve low-impact issues and improve processes.
• Analyze trends and metrics to identify and address non-compliance and enhance operational efficiency.
• Review audit findings and ensure timely resolution with responsible parties.
• Develop and deliver training materials on regulatory updates, best practices, and procedural changes.
• Perform other related duties as needed.

What you'll need (Required):

• University degree and some years of relevant work experience e.g. clinical trials, clinical compliance, clinical monitoring, regulatory compliance or quality assurance/control etc.
• Full proficiency in English, other language is a plus.  
   

What else we look for (Preferred):

• High attention to detail, solid problem-solving, organizational, and analytical abilities
• Strong computer skills with the ability to efficiently use various software tools and adapt to new technologies quickly.
• Working knowledge of clinical compliance policies and procedures
• Familiarity with medical device regulations (e.g., FDA, ISO 14155/13485, ICH)
• Ability to stay current on clinical laws, regulations, and standards