As the largest pureplay adhesives company in the world, H.B. Fuller’s (NYSE: FUL) innovative, functional coatings, adhesives and sealants enhance the quality, safety and performance of products people use every day. Founded in 1887, with 2023 revenue of $3.5 billion, our mission to Connect What Matters is brought to life by more than 7,000 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.

Regulatory Affairs Specialist

Hybrid Position / Hudson, NC

Starting at $24.00/hr based on experience

This individual will be involved in a cross-functional team working with Quality, Customer Service, Research and Development and Manufacturing in a highly regulated industry. This individual will specialize in the evaluation of production processes and performance in manufacturing and participates in projects to engineer quality improvements of existing production processes as well as the development of new processes to improve quality and efficiency. This individual will also have experience in supplier qualifications, audits, regulatory body audits, and interactions with government agencies.

Primary Duties:

• Acts as a resource to operations teams and problem-solving groups and aids in resolution of problems.
• Assists Operations and Quality Operations in implementing corrective action for process deviations, assisting with CAPA initiatives.
• Acts as a resource for our internal and external customers in quality questions.
• Provide timely feedback to customers with complaints.
• Document and submit Medical Device Reports as necessary, and as needed, work with international distributors for Medical Device Reports.
• Supports audits from a complaint and CAPA perspective.
• Assures that operators are following written instructions and methods and procedures via real-time record review.
• Assist with trainings, Management Review, and other administrative tasks as needed.

Minimum Requirements:

• 3 years related experience with HS Diploma (preferably in a cGMP environment); 2 years related experience with associate’s degree; or a Bachelor degree with no experience.
• Fluent in English

• Demonstrates proficiency in the following competencies:
• Innovation – Leveraging possibility thinking in creating new value for customers
• Accountability – Delivering excellence through personal motivation and engagement
• Performance Excellence – Elevating the performance bar and delivering on commitments with high quality solutions
• Change and Risk Taking – Working toward our future, altering the course as needed and balancing risks and rewards in making decisions
• Customer Focus – Understanding customer needs and delivering superior solutions with passion
• Teamwork – Encouraging collaboration, trust and cooperation among and within work groups Click on the link to learn more about H.B. Fuller’s Competencies

Preferred Qualifications:

• Quality experience in a Quality Assurance arena highly preferred.
• Direct experience of working with ISO 13485, FDA 21CFR Part 820 and FDA 21 CFR Part 11 preferred.
• Experience with eQMS systems preferred.
• Prior medical device, ISO 13485, MDSAP, EU MDR or single use experience preferred.

Physical Environment:

• Lifting < 50 lbs. Walking, sitting, focus on computer screen for long periods.
• Able to gown, wear PPE, and work successfully in a clean room environment

Pay is based on several factors including but not limited to education, work experience, certifications, and geographic location.

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.