We are looking for an experienced Regulatory Affairs Specialist to join our growing Regulatory Affairs team. In this role, you will help drive global regulatory strategies and ensure compliance throughout the product lifecycle of our innovative cardiovascular medical devices. You will work closely with cross-functional teams to support product development, regulatory submissions, design changes, and market access, playing a key role in bringing life-changing technologies to patients around the world.
Responsibilities
Prepare, review, and maintain regulatory submissions and registrations for medical devices in global markets, with a primary focus on the U.S. (FDA) and European Union (EU MDR).
Support regulatory strategy development for new product introductions, design changes, and lifecycle management activities.
Manage Engineering Change Orders (ECOs) from a regulatory perspective, including assessment of regulatory impact, documentation updates, and submission requirements.
Compile, maintain, and update technical documentation, regulatory dossiers, and supporting documentation in accordance with regulatory requirements.
Ensure compliance with EU MDR, FDA regulations, and applicable international standards throughout the product lifecycle.
Monitor changes in regulatory requirements and assess their impact on existing and future products.
Collaborate cross-functionally with R&D, Quality Assurance, Clinical, Manufacturing, and Marketing teams to ensure regulatory compliance.
Support regulatory assessments, risk management activities, labeling reviews, and design change evaluations.
Participate in audits and inspections and provide regulatory support for quality management system activities.
Maintain regulatory records and ensure timely renewals, registrations, and submissions.
REQUIREMENTS
Bachelor's degree in Life Sciences, Biomedical Engineering, Engineering, Pharmacy, or a related field.
4–8 years of Regulatory Affairs experience within the medical device industry.
Proven experience with medical device regulatory submissions and registrations in the United States and Europe.
Strong knowledge of FDA medical device regulations and European Medical Device Regulation (EU MDR 2017/745).
