Senior Manager, Regulatory Compliance / Affairs
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 you'll make a difference:
This is an exciting opportunity to make an impact on our business through the regulatory strategy. This role has multi-site responsibility in North America.
What you'll get to do:
* Create and implement the 3-5year regulatory strategy for NA LCD that supports growth and compliance readiness.
* Lead the regulatory compliance and regulatory affairs function for North America within the Lab Consumables Division.
* Manage a team (5-7 team members) of regulatory specials and raw material compliance to assure business needs are supported while achieving compliance to worldwide regulations (FDA, ISO, CMDR, IVD/CE etc.).
* Act as the single point of contact for communication with the FDA for post market (Recalls, HHE, MDRs etc.).
* Coordinate and lead continuous improvement projects related to regulatory processes with all LCD global sites.
* Develop clear visibility to new regulations, translate those regulations into operational requirements for site QM's to implement within sufficient lead-times.
* Manage new product development regulatory plans working with product and R records keeping in compliance with company policy and regulatory requirements (e.g. IVDR, MDR, CMDR,JPAL ISO13485:2016)
* Ability to communicate efficiently with the experts in other scientific and technical fields, and a willingness to learn new skills
* Enhanced PC knowledge and skill sets utilizing Microsoft Office (Word, Excel, PowerPoint)
* Ability to handle conflict with confidence and integrity
* Sound organizational skills
* Must be able to multi-task
* Total Quality Management process experience
* Experience leading audits
* MS in Regulatory Affairs
* Experience in business or product management in _in vitro_ diagnostic regulated industry
* Medical Device audit certification(s)
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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.