Regulatory Affairs Specialist - Nordson

Collaboration drives Nordson’s success as a market leader in Industrial Precision Solutions and Advanced Technology. Our employees thrive in an environment where we help each other reach our personal best and enable our company to continuously improve and grow, and our customers to succeed. You will find Nordson employees sharing our success by giving back in the communities around the world where we live and work.

Nordson MEDICAL designs, engineers and manufactures complex devices and components with applications in wound healing, surgical and minimally invasive, fluid management, pulmonology and interventional and structural heart.Our pioneering Advanced Polymers team was the first to manufacture and supply medical balloons to the medical device industry. Nordson MEDICAL workswithdoctors, start-ups and large medical companies around the world at any point in the product lifecycle, from concept to launch and beyond. 

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.

Nordson Corporation provides equal employment opportunity to all applicants and employees. No person is to be discriminated against in any aspect of the employment relationship due to race, religion, color, sex, age, national origin, ancestry, disability, sexual orientation, gender identity, genetic information, citizenship status, marital status, pregnancy, veteran status or any other status protected by applicable federal, state, or local law. All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check, consistent with applicable laws.Third party recruiters and agencies should not contact employees of Nordson or its subsidiaries directly. Any resumes sent to a hiring manager or submitted to Nordson employees are considered unsolicited and property of Nordson. Nordson will not pay a placement fee unless the agency or recruiter has a signed contract with Nordson’s Human Resources department in advance of submitting a candidate for consideration. Verbal and written approvals will not be considered a valid contract for service.