J&J Family of Companies Senior Regulatory Affairs Program Lead EMEA (m/w/d) in United States
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.
Senior Regulatory Affairs Program Lead EMEA (m/w/d)
Location: Remote - EMEA
YOUR TASKS & RESPONSIBILITIES:
The Sen. RA Program Lead EMEA prepares, assembles, and submits regulatory applications to Competent Authorities / Notified Bodies for achieving registrations for medical devices in the EMEA region.
Carry out regulatory submissions and change submissions to Competent Authorities / Notified Bodies
Review of registration dossiers / technical files and labeling (e.g., package insert) for Regulatory compliance prior to submission to Competent Authorities / Notified Bodies
Provide RA support to achieve local registrations and market authorizations in the EMEA region and supporting other regional RA departments which rely on the European registrations
Global Regulatory impact assessments for all changes at the manufacturing sites and ensuring submission of relevant changes
Responsibility for Regulatory distribution release for medical devices
Review (in view of compliance with regulatory requirements) and approve text drafts and artworks of labels packaging and instructions for use for assigned products.
Supporting the Regulatory Affairs part of Notified Body audits at manufacturing sites or remote.
Supporting new product development with Regulatory Strategy and facilitating Notified Body pre-submission meetings.
Under general supervision, works within established guidelines and has flexibility as to method, priority, and timing of job duties. Requires some amount of initiative and judgment.
Education and/or Experience :
University degree in life sciences or medical device engineering (e.g., chemistry, biology, pharmacy, medical or optical engineer).
Regulatory knowledge especially in EMEA medical products / medical device regulations and ideally experience in CE marking of medical devices (class IIa and above; for 5 years and more); experience with CE marking of ophthalmic medical devices is of advantage.
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
This is what awaits YOU at J&J:
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.
AMO Germany GmbH (7137)
J&J Family of Companies
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