Sr Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

As the largest pureplay adhesives company in the world, H.B. Fuller's innovative, functional coatings, adhesives, and sealants enhance the quality, safety, and performance of products people use every day. Founded in 1887, with 2024 revenue of $3.6 billion, our mission to Connect What Matters is brought to life by more than 7,500 global team members who collaborate with customers across more than 30 market segments in over 140 countries to develop highly specified solutions that enable customers to bring world-changing innovations to their end markets.

H.B. Fuller is seeking a highly skilled and detail-oriented Senior Regulatory Affairs Specialist to support our global regulatory objectives. This individual will play a critical role in ensuring our medical devices comply with regulatory requirements and standards across multiple markets. The position involves preparing and managing submissions, maintaining compliance with global regulations, and collaborating cross-functionally to support product development and lifecycle management.

Primary Responsibilities

• Prepare, review, and submit regulatory documents including FDA 510(k), PMA, De Novo, pre-submissions, and EU MDR technical files.
• Develop regulatory strategies for new products and modifications.
• Monitor submission status and communicate updates to stakeholders.
• Serve as primary contact for FDA (CDRH), Health Canada, EU Notified Bodies, TGA, PMDA, and others.
• Manage regulatory meetings, audits, and inspections.
• Respond to agency inquiries with complete and timely information.
• Ensure compliance with FDA 21 CFR Parts 820 & 11, EU MDR (2017 / 745), ISO 13485 : 2016, MDSAP and other country-specific regulations.
• Maintain global regulatory documentation and licenses.
• Ensure labeling and packaging meet global UDI requirements, FDA GUDID, EU MDR UDI, GS1 GTIN, UBICC
• Collaborate with Supply Chain and Labeling teams for accurate product identification.
• Partner with R&D, QA, Supply Chain, Marketing, and Clinical Affairs.
• Support audits and inspections.
• Mentor junior regulatory staff and contribute to team development.

Minimum Requirements

Preferred Requirements

This position is not eligible for work visa sponsorship. Applicants must have U.S. work authorization that does not now or in the future require H.B. Fuller sponsorship of a work visa to work for H.B. Fuller.

Pay is based on several factors including but not limited to education, work experience, certifications, and geographic location. The salary for this role is $90,000 - $115,000. In addition to your salary, H.B. Fuller offers employees a competitive total rewards package including comprehensive benefits, incentive and recognitions programs, health & wellness benefits, 401K contributions, paid time off and paid holidays. Eligibility may vary.

H.B. Fuller is an Equal Employment Opportunity employer and proud to have created a collaborative culture where employees around the world are seen, heard, and respected. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, or marital status or status as a protected veteran, or any other legally protected classification. H.B. Fuller does not accept unsolicited resumes from recruiters, employment agencies, or staffing firms. To conduct business with H.B. Fuller, a written service agreement must be executed by Human Resources prior to submitting any information relating to a potential candidate. Without a signed service agreement, H.B. Fuller shall not be obligated for payment of any fee or compensation.