Regulatory Compliance Specialist Job Description
This is a challenging opportunity to work as a Regulatory Compliance Specialist. As a key member of our team, you will be responsible for ensuring that our products and services comply with all relevant regulations and standards.
Key Responsibilities:
* Develop and execute regulatory strategies for product registration, approval, and compliance.
* Manage day-to-day regulatory activities as well as handle multiple projects related to regulatory compliance enhancements.
* Manage regulatory submissions, including the preparation, maintenance, review, and submission of regulatory documents and applications to health authorities.
Requirements:
* Bachelor's degree in Engineering or Science with a minimum of 6 years of regulatory experience in the medical device industry.
* Regulatory certifications in EU MDR and US FDA desirable.
* Thorough understanding and knowledge of ISO 13485, ISO 14971, EU MDR, UK MDR, MDSAP, 21 CFR 820, and supporting standards.
* Proven track record with the ability to successfully manage projects to deadlines.
Benefits:
* Competitive salary, bonus, pension, healthcare, and excellent opportunities to develop your career and experience in an exciting company.
* Able to work collaboratively with cross-functional teams to integrate regulatory requirements into QMS and product development processes.
About Us:
We are a dynamic organization that offers a stimulating work environment and opportunities for growth and development.