Regulatory Affairs Specialist

Thermo Fisher Scientific - Asheville, NC

Job Description
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.

Position Summary:
This position is a divisional role and one of the Regulatory Affairs team members supporting North America, other regions as needed, and Original Equipment Manufacturer (OEM), for the Laboratory Products Division (LPD). The North American arm of the Regulatory Affairs team for LPD is responsible for facilitating and executing regulatory strategy defined by the LPD Director of Regulatory Affairs. This position assists the RA team and customers in providing regulatory guidance and support as it applies to the use of LPD’s products and services. This position may also assist the RA team interact with the OEM Customer’s Regulatory Affairs representatives applicable to the region to support global submissions and resolve regulatory issues. In addition, this position will support adherence to established processes, policies and procedures of the company and external regulatory agencies.

Assist, create, support and maintain content management for the RA team
Assist in the coordination, evaluation and implementation of LPD’s regulatory strategy and compliance programs through the review, consultation, training and support of each discipline (Engineering, Operations, Quality, Sales, Sourcing etc) to fulfill their business goals in a compliant manner.
Assist and support Regulatory Affairs network of people and resources in North America to provide local general regulatory support in the regions and time zones where LPD facilities operate with additional review and consultation for more detailed regulatory needs from centers of compliance excellence.
Assist is assembling document dossiers to support medical devices registrations.
Assist in the responsibility for reducing product liability while driving towards achieving our 20:20 vision of world class product compliance by 2020.
Must support and help effectively manage through the RA team any identified non-conformity or product liability discovery or incident.
Assist in providing support to customers relative to compliance issues.
Act as a change agent for improvement initiatives
Perform all job duties in a safe manner and obey all safety policies and procedures
Perform as a Role Model Leader, acting in compliance with the Thermo Fisher Code of Ethics and the 4-I Values (Integrity, Intensity, Involvement and Innovation).
Perform all job duties within ISO standards, regulatory or statutory requirements.

Non-Negotiable Hiring Criteria:
Education: B.S./B.A in technical or business related field.
Strong organization, time management and written communication skills.
Adaptability and flexibility to manage changing demands and handle substantial time pressures.
Working knowledge in problem solving related to content management.
Comfortable working with interdisciplinary teams and effectively coordinates and where appropriate leads efforts from various internal functional groups, which will result in collective team achievements
At Thermo Fisher Scientific, each one of our 70,000 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.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance.
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.