The Regulatory Affairs Specialist III will serve as a member of the Thermo Fisher Scientific Life Technologies, Regulatory Affairs team and will be responsible for providing global regulatory affairs and regulatory compliance guidance and support to the Frederick, MD facility. The Regulatory Affairs Specialist III will support regulated and non-regulated IVD products in respect to regulatory compliance matters to assist the company in achieving its business goals and pursuing opportunities while ensuring compliance with various governmental regulations. The Regulatory Affairs Specialist III will also assist customers by providing regulatory guidance and support as it applies to the use of its products and services.
- Prepare U.S. 510(k) regulatory submissions, preparation/maintenance of Technical Files for European CE-IVD products, preparation/renewal of CMDL for Canada.
- Prepare regulatory submissions for health authorities in other countries.
- Prepare and maintain state and federal medical device licensing, establishment registration and listings.
- Prepare product field action and MDR reports
- Obtain regulatory permits, including compliance with import / export clearance requirements and regulations.
- Regulatory assessment of new and existing products.
- Labeling / marketing material review.
- Participate in project teams (existing products and new product introductions)
- Keep abreast of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.
- Conduct training and/or communicate appropriate material to internal staff to aid in compliance.
- Develop regulatory affairs internal policies and procedures, and provide compliance training.
- May perform audits, both physical and paper, to ensure compliance with various regulations.
- May coordinate audit through outside vendor.
MINIMUM QUALIFICATIONS (must haves):
- Must have a minimum of 5 years of Regulatory Affairs experience (primarily In-Vitro Diagnostic Medical Device technical work experience) or an equivalent combination of education and experience.
- Regulatory certification is a plus.
- In-Vitro Diagnostic/Medical Device regulatory affairs: Regulations, Submissions (510(k), PMA, IDE), Technical Files (IVDD), CMDL, cGMP/Quality Systems, Regulatory Compliance and Import/Export regulations.
- Direct and positive experience in communicating with Regulatory Authorities and Distributors.
- Multi-site experience, in a mid to large size company.
- A minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science. M.S. or M.B.A. is a plus.
- High energy level; positive attitude; works well under stress
- Strong communicator
- Hands-on, action-oriented, and able to implement effectively through his/her team
- Continuous improvement minded; used to balancing the need for Quality and the need for efficiency
- Able to work autonomously in a matrix-managed organization
- Willingness to travel (~40%)
- Comfortable with ambiguity and change
- Good business sense for what’s practical, and what’s not, what’s needed for what parts of the business.
- Good sense for Operations in general.
- Able to effectively operate in a cost-conscious environment.