Regulatory Affairs Specialist

19 Nov, 2020

Jobs

Regulatory Affairs Specialist

Nordson
Eagan, MN

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 works with doctors, start-ups and large medical companies around the world at any point in the product lifecycle, from concept to launch and beyond.

ESSENTIAL JOB DUTIES & RESPONSIBILITIES

  • Follows all procedures and Company policies insuring that regulatory requirements are achieved in an ethical manner.
  • Meets commitments on time with accuracy and attention to detail
  • Assists in development of regulatory strategies
  • Assists in preparation of US FDA submissions
  • Provides customers with documentation for international submissions
  • Creates/Maintains Technical Files
  • Reviews product/manufacturing changes [Change Orders (COs)] for compliance with regulations
  • Reviews protocols and reports to support regulatory submissions
  • Keeps current on changing global regulations, product line and customer needs
  • Obtains and maintains GTIN numbers and GUDID Registrations
  • All other duties as assigned

EDUCATION & EXPERIENCE REQUIREMENTS

  • Bachelor’s Degree (Technical or Scientific Discipline Preferred)
  • 1-3 years’ experience in Regulatory Affairs in a medical device company
  • Must have experience working with Class II medical devices
  • Good working knowledge of FDA 510(k)/labeling, MDD, and CMDCAS requirements
  • Experience with Microsoft Office Suite (Outlook, Word, Excel, PowerPoint)

SKILLS & ABILITIES

  • Excellent written and verbal communication skills
  • Strong interpersonal skills to work across international organization
  • Establishes and cultivates communication and team oriented network of support to facilitate completion of assignments
  • Demonstrates objective critical thinking and problem-solving skills
  • Exercises judgment in selecting innovative, practical methods to achieve problem resolution
  • Ability to manage multiple priorities
  • Good planning and organizational skills, ability to work in a small team as well as independently

WORKING CONDITIONS & PHYSICAL DEMANDS

Office & manufacturing environment. 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.

TRAVEL REQUIRED       

  Estimated 10%

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.

NORDSON1

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.

Whatever you do today, Nordson Corporation is likely a part of it. We engineer, manufacture and market differentiated products and systems used for precision dispensing and processing in a variety of end markets, from packaging to transportation and medical to electronics. Founded in 1954, we operate under the values of integrity, respect for people, customer passion, energy and excellence. Nordson is headquartered in Westlake, Ohio, and has direct operations in more than 30 countries to support our products and systems with application expertise and a direct global sales and service organization.

Learn more here

Job posted: 2020-11-19