Regulatory Affairs Specialist
The Regulatory Affairs Specialist will provide regulatory support for new and existing products. Responsibilities include implementing regulatory plans and complete regulatory deliverables for medical devices.
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
- Develops regulatory strategies
- Prepares US FDA submissions
- Provides customers with documentation for international submissions
- Creates/Maintains Technical Files
- Effectively plans and drives successful completion of regulatory submissions
- Review of product/manufacturing changes [Document Change Orders (DCOs)] for compliance with regulations
- Review of protocols and reports to support regulatory submissions
- Keeps current on changing global regulations, product line and customer needs
- All other duties as assigned
EDUCATION & EXPERIENCE REQUIREMENTS
- BA or BS Degree (Technical or Scientific Discipline)
- At least eight 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.
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.
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