Regulatory Expert - Medical Devices

Work Your Magic with us! 

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimaginable with us.

The Role

We are actively seeking a Regulatory Expert – Medical Device to join our dynamic team at Cork (1 Year FTC). As a hybrid role, you will support to manage assigned regulatory tasks related to health authority notifications, submissions, and registrations regarding renewals and new products, and changes to products or sale of products in new territories ensuring continual compliance to all applicable regulations and support ensuring that site regulatory strategy aligns with overall corporate regulatory strategy, goals, and objectives

• Compile and maintain technical files and other relevant regulatory documentation to guarantee timely registrations and renewals
• Performs surveillance and advocacy activities for medical devices according to assigned tasks
• Provide support and counsel in tasks pertaining to regulatory registrations, listings, and compliance, with specific emphasis on adhering to the Medical Device (EU) 2017/745 (MDR) and In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR); maintaining compliance with requirements of FDA 21 CFR 820, ISO 13485:2016, and other applicable International Medical Device Regulations
• Support regulatory review for CAPA investigations, adverse events, validations, and general projects (removed printed materials & added adverse events)
• Support preparation of and participate in regulatory authority audits and customers
• Support regulatory review of labeling materials including labels, instructions for use, package inserts promotional materials and provide consultancy to ensure regulatory compliance

Who you are:

Minimum Qualifications:

• Master’s or Bachelor’s degree in pharmacy, Chemistry, Biology, Engineering, or other Life Science field with 1+ years experience in medical device/IVD regulatory affairs

Preferred Qualifications:

• Minimum 1 years’ experience in regulatory or quality related fields preferred medical device or in-vitro diagnostics regulations
•  Good communication and organization skills and attention to detail
• Proficient in MS Office Software (Word, Excel, PowerPoint)
• Fluency in English

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology. We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!