What are the responsibilities and job description for the Regulatory Affairs Specialist II, Medical Device (Pittsburgh) position at Thermo Fisher Scientific?
Work Schedule
First Shift (Days)
Environmental Conditions
Office
Job Description
About Us:
Here at Thermo Fisher Scientific, our industry-leading scale means unparalleled commercial reach, unique customer access and a global footprint.
Location: This is an onsite position. Residency near Pittsburg is required. NO relocation assistance.
Key Responsibilities
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.
Qualifications and Requirements
Education:
Bachelor of Science (BS) degree in Science preferred or Associates degree with a equivalent field experience.
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.
Knowledge, Skills, and Abilities:
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.
