Associate Director Ra Emea

Vor 5 Tagen

Zug, Schweiz Johnson & Johnson Family of Companies Vollzeit

**Johnson & Johnson Vision** is committed to improving and restoring sight for patients worldwide. Since debuting the world’s first disposable soft contact lens in 1987, it has been helping patients see better through their world leading **ACUVUE®** Brand Contact Lenses. In 2017, J&J expanded into cataract surgery, laser refractive surgery (LASIK) and consumer eye health and now serves more than 60 million patients a day across 103 countries with its eye health portfolio. Thriving on a diverse company culture, celebrating the uniqueness of our employees, and committed to inclusion.

**ASSOCIATE DIRECTOR REGULATORY AFFAIRS EMEA (M/W/D)**

**Location: Remote or on-site - EU or UK**

**Contract Duration - 2 years**

**YOUR TASKS & RESPONSIBILITIES**:

- The Associate Director RA EMEA Leads the EU/UK team as part of the RA EMEA team at J&J Vision with 10 team members in total and liaises frequently cross-functionally to align on processes/projects.
- Ensures CE marking of our cataract product portfolio, national database registrations in EU/UK for the whole Vision portfolio, supporting labeling review and overlabel activities in local DCs, change control activities, RA market release and supporting the MDR project teams.
- Monitoring and prioritization of resources in support of projects, programs, and initiatives in support of full deployment and execution of goals and objectives of the RA EMEA team.
- Supporting the Regulatory Affairs part of Notified Body and Competent Authority audits at J&J Vision manufacturing sites.
- Supporting new product development with the CE marking Regulatory strategy for Surgical Vision products.
- The position is restricted to two years as it is a maternity leave replacement

**Qualifications**
EDUCATION AND/OR EXPERIENCE**:

- University degree in life sciences or medical device engineering (e.g., chemistry, biology, pharmacy, medical or optical engineer) or a different university degree together with long term experience in the medical device industry
- Regulatory knowledge especially in EU medical device regulations (MDR) and experience in CE marking of medical devices (class IIa and above; for 8 years and more) is required; experience with CE marking of ophthalmic medical devices and ISO13485 is of advantage.
- Leadership experience is required (5 years+)
- Very good English skills (more languages are of advantage)
- Strong attention to detail
- Ability to act in multicultural and cross functional environment essential
- Ability to organize and track complex information

**J&J CAN OFFER YOU**:

- Above average remuneration
- An exciting corporate environment with national and international development opportunities
- Interesting market dynamics, growth orientation and several new product launches

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against based on disability.

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

That is why we in Germany are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”

Severely disabled applicants will be given special consideration if they are equally qualified.

**Primary Location**
Germany-Baden Württemberg-Ettlingen
- **Other Locations**
Europe/Middle East/Africa-United Kingdom, Europe/Middle East/Africa-Czech Republic-Prague-Prague, Europe/Middle East/Africa-Belgium, Europe/Middle East/Africa-Netherlands-Groningen-Groningen, Switzerland-Zug-Zug
**Organization**
AMO Germany GmbH (7137)
**Job Function**
Regulatory Affairs
**Requisition ID**
2206010120W

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