Manager Regulatory Affairs (m/f/d)

☞ Alcon

View: 173

Update day: 07-10-2024

Location: Erlangen Bavaria

Category: Arts / Design

Industry:

Job type: Vollzeit

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At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.

We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As a Regulatory Affairs Manager based in Erlangen, you are responsible for interpreting regulations as they apply to ophthalmic refractive surgery equipment and software practices and procedures as well as investigating and resolving compliance problems, questions received from other units of the company, customers, government regulatory agencies, etc.
KEY RESPONSIBILITIES
  • Provide high quality regulatory affairs expertise and input to internal stakeholders and/or projects as it relates to WaveLight products, including Class 3 devices, computerized system devices, and software as medical devices.
  • Review, assess, and approve process and/or design changes for potential impact on current medical device filings.
  • Manage and/or prepare device regulatory filings in the US, Canada, and EU with a thorough understanding of the FDA, Health Canada, and MDD and MDR regulatory requirements.
  • Assist, review, and/or approve device regulatory filings for markets outside the US, Canada, and EU as requested.
  • Demonstrate organizational and time management skills while exhibiting company Values and Behaviors.
WHAT YOU’LL BRING TO ALCON:
  • Masters Degree or Equivalent years of directly related experience (or high school +10 yrs;)
  • The ability to fluently read, write, understand and communicate in English and German
  • 5 Years at least of Relevant Experience
  • Provide high quality regulatory affairs expertise and input to internal stakeholders and/or projects as it relates to WaveLight products, including Class 3 devices, computerized system devices, and software as medical devices.
  • Review, assess, and approve process and/or design changes for potential impact on current medical device filings.
  • Manage and/or prepare device regulatory filings in the US, Canada, and EU with a thorough understanding of the FDA, Health Canada, and MDD and MDR regulatory requirements.
  • Assist, review, and/or approve device regulatory filings for markets outside the US, Canada, and EU as requested.
  • Demonstrate high organizational and time management skills while modeling company Values and Behaviors.
HOW YOU CAN THRIVE AT ALCON:
  • You get the chance to help people see brilliantly. You will play a big part in making a difference in the lives of patients and be part of a company with a clear purpose, cutting-edge innovation and breakthrough technology in eye-care.
  • Travel Requirements: 0%

Alcon Careers
See your impact at
alcon.com/careers
Alcon is an Equal Opportunity Employer and participates in EVerify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in any employment practices. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If you need a reasonable accommodation for any part of the application process, please send an email to
alcon.recruitment@alcon.com
.
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Deadline: 21-11-2024

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