Regulatory Affairs Specialist II, Medical Device (Pittsburgh)

Work Schedule

Environmental Conditions

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.