Associate Specialist, Clinical Compliance
Join to apply for the Associate Specialist, Clinical Compliance role at Edwards Lifesciences
Associate Specialist, Clinical Compliance
Join to apply for the Associate Specialist, Clinical Compliance role at Edwards Lifesciences
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
Seniority level
* Seniority level
Entry level
Employment type
* Employment type
Full-time
Job function
* Job function
Finance and Sales
* Industries
Medical Equipment Manufacturing
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