Regulatory Affairs Specialist

Nordson Medical, a global leader in Interventional Solutions, Fluid Components, and Surgical Solutions, is seeking an experienced and highly motivated individual to join our team. We are committed to creating a diverse and inclusive workplace, and we are looking for candidates who share that same commitment.

Summary of the role

As a member of our team, you will have the opportunity to work in a dynamic and collaborative environment, where your ideas and contributions will be valued and respected.

Job Summary

The RAS works with the Company's quality assurance system following established procedures, policies, and work instructions to assure regulatory requirements are met. This includes internal and external audits, customer support (surveys & scorecards), document control, training, supplier management, legal agreement management and continual improvements.

Essential Job Duties and Responsibilities

• Document Control -
  • Interface with affected departments to ensure timely processing/approval and release of document changes.
  • Ensure control and availability of current documentation to site personnel.
  • Create and revise work instructions and SOPs as needed to comply with Quality System requirements.
• Audits -
  • Manage the Internal Audit Program, including, but not limited to: scheduling, conducting, and reporting audits; initiate audit findings; distribute and archive audit reports; Assist with on-going training for the internal audit team.
  • Manage or assist with external audits (customer, suppliers and Regulatory agencies) including, but not limited to: preparation, response, action items and follow up.
  • Summarize report of all Audit findings prior to MRM.
  • Regulatory -
  • Assist in compilation of documentation to meet regulatory requirements for new products.
  • Lead actions surrounding maintenance of Regulatory data for ROHS/PFAS/REACH/Conflict Min.

compliance.

• Maintenance of customer facing regulatory documentation.

• Customer Support -
  • Respond to customer inquiries as requested.
  • Manage record-keeping and follow up of customer scorecards (hard copies and electronic).
• Catalog, maintain and archive Legal documents including legal templates and fully executed agreements.
• Support Validation activity as needed.
• All other duties as assigned.

Education and Experience Requirements

• Bachelor's degree (combination of post high school education and applicable experience may be considered).
• Minimum of 3 years of work experience with a medical device manufacturer with emphasis on ISO 13485 quality management system.

Skills and Abilities

• Prior training in ISO 13485
• Experience and knowledge with ISO 13485,
• Excellent communication skills: written and oral
• Excellent interpersonal skills
• Excellent organizational skills and attention to detail
• Ability to prioritize and multi-task
• Skilled in the use of the Microsoft Office Suite

Working Conditions and Physical Demands

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Regularly required to sit, stand, bend reach and move about the facility
• Ability to lift materials and product up to 55 pounds.

Travel Required

Estimated 5%

Nordson Medical offers a comparable benefit package, including:

Pay: $75,500-$84,900 salary

Medical, Dental, Vision Insurance

Short Term Disability / Bereavement / Adoption Assistance / Vacation / 401(k) Match

Long Term Disability / Member Life & AD&D / Family and Medical Leave / Member Optional Life

Spouse/Child Optional Life / Optional AD&D / Healthcare and Dependent Care Flexible Spending

Whole Life Insurance / Critical Illness Insurance / Legal Plan / Military Leave

Position will be posted until 10/30/2024 or until filled.

Interested?

If you are interested in being a part of a team and creating an inclusive and diverse workplace, please apply online with your CV.

About Nordson Medical

At Nordson MEDICAL, you don't have to be a doctor to help save lives. We are the global expert in the design, development, and manufacturing of complex medical devices and component technologies. By joining our team today, you will help us bring innovative ideas to life. Nordson MEDICAL is a global team that works to create components for life-saving medical devices. We offer a supportive culture in a growing and dynamic work environment. Whether you're just beginning your career or you're a seasoned professional, there's a place for you to belong at Nordson MEDICAL. We offer hourly and salary positions in production, maintenance, customer service, quality, engineering, and more. We actively invest in our teams to help you build your skillsets and advance your career.