Regulatory Specialist Engineer III, RA

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll 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 worlds 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 COs 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

Successful Candidate Will Possess

• A positive approach and motivated by challenges
• Team-player mentality
• Dedicated with the ability to handle tasks independently
• Flexibility to handle shifting priorities
• Confidence in collaborating with colleagues at all levels
• Strong written communication skills with technical writing experience being a plus
• Excellent critical thinking and decision-making skills
• A continuous improvement approach
• Innovative problem-solving ability
• Strong organizational skills with attention to detail

How will you make an impact

The Regulatory Specialist will support the Laboratory Plastics Essentials business by working closely with global manufacturing sites including locations in Tijuana (MX) Monterrey (MX) and Roskilde (DE) to ensure overall product safety and regulatory compliance. This position will be responsible for maintaining and updating Technical Documentation on regulated products and ensuring continuous improvement as it relates to changes in global standards and addition the RA specialist will assist with risk analysis or health hazard assessments for product recalls or field actions relating to a non-conforming product. The RA Specialist will also act as a regulatory consultant to ensure all products comply global and regional regulations and market needs (REACH/SVHC California Proposition 65 RoHS).

What will you do

• Ensure availability of up-to-date technical documentation and Standard Operating Procedures
• Work together with LPE global teams for supporting customer requests with related RA mailboxes
• Work with the global environmental compliance team to oversee the management of compliance information for all sourced materials components and finished goods
• Support international registrations with related technical documentation
• Function as an RA subject matter expert on new product introductions capacity expansion projects and custom product development and manufacturing
• Complete timely regulatory safety evaluations on customer complaints and manufacturing non-conformance activities for regulated products
• Provide regulatory input to QA in Deviations CAPAs Management Review and complaints
• Provide guidance regarding regulatory and performance test requirements for product claims and the design verification and validation of products (including sterilization biocompatibility labelling clinical and packaging validation)