Work Schedule
Environmental Conditions
Job Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Position Summary:
Regulatory Specialist is overall responsible for supporting RA with the tasks described as below.
Furthermore, the employee shall provide continuous regulatory support to the organization with review and update of EU MDR/IVDR Technical Files and support to the RA mailbox regarding Change Orders, product related questions, complaints and non-conformities, etc. for sites in Tijuana, Monterrey and Roskilde.
Key Responsibilities:
- Work for regulatory activities in cooperation with the existing RA team and Sr RA Manager
- Support product development by facilitating globally focused regulatory strategies to drive market access.
- Draft regulatory plans and verification reports to ensure products meet regulatory requirements in all target market regions.
- Responsible for updating the CE technical files for medical products.
- Participate in and ensure follow up on customer requests in the RA mailbox.
- Review and approve product development reports, non-conformance reports, product changes, label content and new product data.
- Provide general quality support to the organization e.g. TrackWise, complaint, observations, CAPA, NC, CO’s, product registration and technical file questions etc.
- Additionally, be part of the risk evaluation in related quality tasks.
- Optimize, document and implement RA processes in QMS regarding regulatory procedures.
- Support external and internal audits. E.g. participate in the Notified Body audit back office to provide documentation and explanation for the technical file documentation.
Minimum Requirements/Qualifications:
- Minimum BA/BS degree in a scientific or engineering field (preferred: biology, chemistry, material science, polymer science).
- At least 2 years of experience in a regulated industry (pharmaceutical or medical device).
- Strong working knowledge of US and EU Medical Device and In vitro Diagnostic requirements
- Analytical mind-set and a great ability to learn new professional fields and business processes
- Great ability to structured and goal-oriented manner
- Excellent communication and team-building skills