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Regulatory Affairs Technical Specialist

Job Description

Regulatory Affairs Technical Specialist

Key Responsibilities:

  • Represents Regulatory Affairs on Product Development Core Teams for Point-of-Care (POC) Diagnostics for in vitro diagnostics (IVD) products.
  • Plans and prepares regulatory submissions for new product development to meet the requirements for US, EU (including 510(k)s, Pre-Submissions, Technical Files/STEDS) and collaborates with Siemens Regulatory affiliates worldwide to ensure country specific requirements are met.
  • Supports the regulatory documentation for commercialized products including International registrations, Regulatory Assessments, and 510(k) Note-to-File justifications for product design changes etc.
  • Performs review of promotional material and product labeling for regulatory compliance.
  • Supports internal and external Quality audits/inspections.
  • Interacts closely with multiple functions, including Manufacturing, R&D, Marketing, Logistics, Labeling etc.

Preferred Skills:

- Minimum 5 years experience in Regulatory Affairs, preferably with a global manufacturer of IVD medical devices.

- Experience with managing and preparing complex Regulatory Submissions (510(k)s, PMAs, Pre-Subs, CE Mark Technical Dossiers, and other global regulatory submissions).  

- Must have strong organizational and technical writing skills.

- Must have strong communication skills and work well with a team.

- Must have experience working on multidisciplinary teams in a fast-paced, dynamic environment.
- Must have experience reviewing product labeling, including advertising/promotional materials.

- Must be well versed in QSR Design Control requirements and in educating project teams on these requirements.

Education:

- BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience.  Certification may be required in some areas.



Organization: Siemens Healthineers

Company: Siemens Healthcare Diagnostics Inc.

Experience Level: Mid-level Professional

Job Type: Full-time



Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

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