Regulatory Affairs Expert - Medical Device

Work Your Magic with us! Start your next chapter and join EMD Electronics.

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.

Everything we do in EMD Electronics is to help us deliver on our purpose of being the company behind the companies, advancing digital living. We are dedicated to being the trusted supplier of high-tech materials, services and specialty chemicals for the electronics, automotive and cosmetics industries. We foster a global collaborative organization made up of individuals who have the passion to win, obsess about the customer, are relentlessly curious and act with urgency. Together, we push the boundaries of science to make more possible for our customers.

Your Role:

We are actively seeking a Regulatory Affairs – Medical Device professional to join our dynamic team at Livingston.  As a hybrid role with minimal supervision, you will 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 ensuring that site regulatory strategy aligns with overall corporate regulatory strategy, goals, and objectives. 

Key Responsibilities:

• Autonomously compile and maintain technical files and other relevant regulatory documentation to guarantee timely registrations and renewals
• Independent realization of product registrations, renewals, change submissions
• Support site specifies as well as global cross-site projects, planning and implementation of strategic regulatory projects and initiatives
• Performs surveillance and advocacy activities for medical devices according to assigned tasks
• Carry out regulatory registrations, listings, and compliance related tasks, with specific emphasis on adhering to the In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), FDA Biological license for further manufacturing use and Medical Device (EU) 2017/745 (MDR); maintaining compliance with requirements of FDA 21 CFR 600 & 820, ISO 13485:2016, and other applicable International Medical Device Regulations
• Manage regulatory review for CAPA investigations, change controls, adverse events, validation and other documents, promotional materials and general projects
• Support preparation of and participate in audits by regulatory authorities and customers
• Responsible for regulatory review of labeling materials including labels, instructions for use, package inserts promotional materials and provide consultancy to ensure regulatory compliance
• Support new product development projects through regulatory assessments
• Address regulatory queries and requests from both internal stakeholders and external customers
• Act as regulatory contact for other departments at the site

Who you are:

Minimum Qualifications:

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

Preferred Qualifications:

• Established experience in medical device and in-vitro diagnostics regulations (MDD/MDR IVDD/IVDR and US FDA)
• Advanced knowledge of medical device and IVD regulations within Europe and North America.
• Experience in interpretation of regulations, guidelines, policy statements, etc. and in interfacing with relevant regulatory authorities
• Advanced written, and interpersonal communication skills including proficient knowledge of medical terminology
• Excellent organizational, prioritization, and problem-solving skills
• Excellent project management skills
• Capability to work independently while adeptly handling multiple tasks/projects with varying deadlines and specifications
• Proficient in MS Office Software (Word, Excel, PowerPoint)
• Competence in thriving within both collaborative team environments and individual work settings with minimal oversight
• Excellent written and verbal communication skills and 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 and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html