Senior Regulatory Affairs Specialist

@ H.B. Fuller

About H.B. Fuller

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 everyday products. Founded in 1887 with revenues of $3.6 billion in 2024, the company connects what matters through a global team of over 7,500 members.

Role Overview

The Senior Regulatory Affairs Specialist supports global regulatory objectives by ensuring medical devices meet regulatory standards across multiple markets. You will prepare and manage submissions, maintain regulatory compliance, and collaborate with cross-functional teams.

Primary Responsibilities

• Regulatory Submissions & Strategy: Prepare, review, and submit regulatory documents (FDA 510(k), PMA, etc.). Develop strategies for new products and modifications. Monitor submission status and update stakeholders.
• Liaison with Regulatory Authorities: Act as primary contact for agencies including FDA, Health Canada, EU Notified Bodies, and more. Manage meetings, audits, and inspections while responding promptly to inquiries.
• Global Regulatory Compliance: Ensure adherence to FDA 21 CFR Parts 820 & 11, EU MDR, ISO 13485:2016, MDSAP, and other standards. Maintain regulatory documentation and licenses.
• UDI, GTIN, and UBICC Compliance: Ensure labeling and packaging meet global UDI requirements and collaborate with relevant teams.
• Cross-functional Collaboration: Work with R&D, QA, Supply Chain, Marketing, and Clinical Affairs. Mentor junior staff and support audits and inspections.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, Regulatory Affairs, or related field.
• Minimum 5 years' experience in Regulatory Affairs for medical devices.
• Experience with FDA and international submissions, including UDI systems.
• Familiarity with Class II and III medical devices.
• Excellent English communication skills.

Preferred Attributes

• RAC certification and deep understanding of global regulations.
• Strong written and verbal communication style.
• Proficiency in Microsoft Office, regulatory submission tools, and eQMS systems.
• Experience with single-use medical devices.
• Willingness to travel up to 10% for meetings and audits.

Additional Information

This position is not eligible for visa sponsorship. Applicants must have U.S. work authorization that does not require current or future sponsorship.

Compensation & Benefits

The salary range for this position is $90,000 - $115,000. H.B. Fuller offers a competitive total rewards package including comprehensive benefits, incentive and recognition programs, health & wellness benefits, 401K contributions, and paid time off.

Key skills/competency

• Regulatory Submissions
• Compliance
• Medical Devices
• Global Regulations
• FDA
• EU MDR
• Quality Assurance
• Audit
• Cross-functional Collaboration
• Documentation