Regulatory Affairs Specialist

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Product Submissions and Registration

Job Category:

Professional

All Job Posting Locations:

Karlsruhe, Baden-Wurttemberg, Germany, Lisbon, Portugal, Madrid, Spain

Job Description:

Internal Job Posting –

About J&J Vision

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding on the possibilities of vision treatments? Ready to join a team that's reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs – from the pediatric to aging eye – in a patient's lifetime.

Your unique talents will help patients on their journey to wellness. Learn more at 

We are searching for the best talent for a Regulatory Affairs Specialist (m/f/d)

The Specialist Regulatory Affairs supports the Manager of Regulatory Affairs in key duties and responsibilities, including:

• Providing RA support to achieve local registrations and market authorizations in the EMEA region, submitting to national authorities, and supporting other regional RA departments with Regulatory documentation.

• Reviewing and approving promotional materials, artworks of labels, packaging, and instructions for use for assigned products.

• Conducting global regulatory impact assessments for changes and ensuring the submission of relevant updates to the Competent Authority.

• Supporting the Regulatory Affairs Manager with regulatory distribution releases for medical devices.

• Assisting in the preparation, creation, and copy review of Vision Care product labeling in accordance with RA requirements and internal labeling processes for the EMEA region.

• Supporting regulatory labeling projects by tracking processes, including timely entries in regulatory databases and systems, as well as ensuring compliant document archiving for assigned projects.

• Communicating with internal and external partners to support regulatory affairs labeling projects.

• Supporting interactions with internal and external stakeholders as needed to ensure uninterrupted product supply.

• Demonstrating the ability to create and modify materials (using InDesign and Adobe Pro) quickly, ensuring agility across all subsequent processes, including production and sales.

Experience/Knowledge :

• A university degree in medical device engineering, life sciences, law, or extensive experience in the healthcare industry is required.

• Good English skills, both written and verbal.

• Additional language skills are a plus.

• Strong attention to detail and a commitment to quality.

• Ability to operate effectively in a multicultural and cross-functional environment is essential.

• Proven ability to manage multiple projects simultaneously.

• Experience with healthcare industry is an advantage.

This is what awaits YOU at J&J:

• An opportunity to be part of a global market leader
• A dynamic and inspiring working environment
• Many opportunities to work on challenging projects and assignments
• Possibilities for further personal as well as professional development
• Many employees benefits

If you wish to include or request support from the company's representative for severely disabled people as part of your application process, please proactively inform the responsible recruiter when you are first contacted by our Talent Acquisition Team – thank you.

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