Regulatory Affairs Specialist II, Medical Device (Pittsburgh)
- Pittsburgh, PA
- Permanent
- Full-time
- As a Regulatory Affairs Specialist II, you will be responsible for the following tasks:
- Participate in all aspects of the regulatory function, including reviewing items/products for onboarding, addressing specific product inquiries, and tracking departmental metrics.
- Apply internal screening processes to conduct daily comprehensive regulatory reviews of new products.
- Ensure product compliance with applicable federal, state, and international regulations, including 21 CFR Part 820 and National Association of Boards of Pharmacy (NABP) regulations.
- Organize and validate device data for submission and registration with the FDA GUDID database.
- Assist with customer order approvals, including medical devices for other international divisions.
- Maintain required regulatory permits and licenses.
- Perform regulatory surveillance for new or changing regulations with federal agencies.
- Assist the Distribution Centers, Customs Compliance, and Supply Chain Departments as required.
- Assist with compliance audits, both internal and external.
- Prepare various regulatory compliance reports for submission to government agencies as applicable.
- Participate in Regulatory Group projects, PPI-Teams, and system-application improvement initiatives.
- Develop Work Instructions for core regulatory functions and update existing Standard Operating Procedures (SOPs) as needed.
- Collaborate with internal and external departments to facilitate problem resolution.
- Bachelor of Science (BS) degree in Science preferred or Associates degree with a equivalent field experience.
- A minimum of 5 years of proven experience in regulatory affairs, ideally within the medical device or pharmaceutical industry.
- Strong understanding of FDA regulations, as well as state and international regulations related to medical devices.
- Demonstrate ability to maintain regulatory permits and licenses, including Board of Pharmacy licenses and applicable accreditations.
- Proficiency in preparing regulatory compliance reports and performing regulatory surveillance.
- Outstanding attention to detail and ability to perform comprehensive regulatory reviews.
- Excellent interpersonal, customer orientation, and presentation skills.
- Proven time management and decision-making skills.
- Experience in multi-tasking, flexibility, and understanding of business impact to address immediate priorities while handling deadlines with longer-term projects and critical initiatives.
- Excellent verbal and written communication skills across a diverse range of colleagues.
- Ability to work in a highly matrixed environment, inclusive of conflict resolution.
- Ability to drive resolution of issues by working collaboratively with colleagues.
- Ability to align with Thermo Fisher values of Integrity, Intensity, Innovation, and Involvement.
- Ability to understand federal and state regulations/requirements to offer guidance and solutions to leadership for compliance.
- Willingness and ability to learn complex regulatory and compliance regulations, laws, and requirements and apply them to the current business environment.