When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
How will you make an impact?
The Regulatory Compliance Project Manager will lead the implementation and compliance management for the Unique Device Identification (UDI)/GS1 initiative spanning multiple sites including international within the Anatomical Pathology Division (APD). Lead auditing across multiple sites ensuring compliance and harmonization of processes/procedures. Partner with cross-functional teams in Sourcing, Manufacturing, Engineering, and Quality to accomplish deliverables within timeline and budget. Provide support to RoHS/REACH initiatives. This role reports to the VP of Quality/Regulatory Affairs. This role could be based in Portsmouth, NH or Kalamazoo, MI or Pittsburgh, PA or Oakwood Village, OH.
What will you do?
- Lead a major initiative to implement UDI/GS1 across multiple plants by working closely with each site to understand the compliance requirements related to products, documentation, labeling, training requirements, etc., for a Class I product.
- Work with each site to identify product SKUs, registration requirements related to trade compliance, understand the documentation requirements related to UDI/GSI, and drive successful adoption/implementation of project while ensuring compliance and process harmonization.
- Develop training and support programs to ensure proper understanding and on-gong support of program.
- Support RoHS/Reach Compliance by working with different cross-functional teams.
- Lead auditing activities for multiple sites as division representative.
- Develop standard operating procedures (SOPs) to harmonize UDI/GS1, trade compliance, and RoHS/REACH requirements.
- Develop KPIs/metrics to measure compliance performance.
- Provide compliance support for projects helping to achieve Site, Business Unit, Division and Company goals.
- Establish effective working links with other Thermo Fisher professionals in order to improve processes and compliance.
- Responsible for performing tasks to support the quality system and quality policy as directed by QA/RA management.
How will you get here?
- Bachelor's degree or equivalent combination of education and experience to perform at this level.
- A minimum of 5 years of professional experience working with Quality, Regulatory, and/or Compliance with broad knowledge of medical device regulations.
- Experience working with UDI/GS1 -Required
- Experience with RoHS/REACH –A plus
- Experience working with medical device/IVD regulated products.
- Experience in internal auditing, preferably as a lead auditor.
- Experience of working with cross functional teams.
- Knowledge of ISO13485/ FDA QSR Part 820 requirements with particular focus of supplier controls, supplier performance management, CAPA and management review.
- Knowledge of quality investigation and improvement tools - 8D, Cause & Effect, FMEA, 5 Whys, etc.
- Excellent interpersonal and communication skills both - written and oral.
- Ability to work in a timeline driven environment with excellent project management skills.
- Strong proficiency with Word and Excel.
- Up to 40% travel globally.
At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.