Johnson & Johnson Careers

Regulatory Affairs Manager (m/f) – Medical Devices

Rhein-Kreis Neuss, Germany
Regulatory Affairs


Job Description

Requisition ID: 1805621421W

Johnson & Johnson is the world´s most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services. The values that guide our decision making are motivated by a culture of caring. Caring for the world ... one person at a time? Inspires and unites the people of Johnson & Johnson. The company is operating in the fields of pharmaceuticals, medical advices and consumer health care products with 117,000 employees in more than 250 companies around the world. In Germany the Johnson & Johnson GmbH represents the consumer health care business. With a broad portfolio of well-known brands we are in touch with the consumer at every stage of life.

 

We are currently looking for a

 

Regulatory Affairs Manager (m/f) – Medical Devices

 
Job description:
 

Drawing on relevant expertise and information from both internal and external sources, make a major contribution towards the preparation of any critical regulatory documentation for notifications in the Medical Device area.

 
Responsibilities:
  • Ensuring that the company's products comply with relevant legislation and standards
  • Keeping abreast of international legislation, guidelines and customer practices
  • Keeping up to date with a company's product range
  • Developing and writing clear strategies and arguments and explanations for new product licenses, modifications and license renewals
  • Preparing submissions of license variations and renewals
  • Setting and communicating timelines for license variations and renewal approvals
  • Writing clear, accessible product labels and patient information leaflets
  • Planning and developing product trials, Interpreting trial data
  • Advising scientists and manufacturers on regulatory requirements
  • Resolving complex issues as they arise
  • Project managing teams of colleagues involved with the development of new products
  • Maintaining quality systems undertaking and managing regulatory inspections
  • Reviewing company practices and providing advice on changes to systems Liaising with, and making presentations to regulatory authorities and Notified Bodies
  • Submitting license and clinical trials applications to authorities to strict deadlines
  • Negotiating with regulatory authorities and Notified Bodies for marketing authorization
  • Specifying storage labelling and packaging requirements. Liaising closely with the regulatory authorities on a regular basis 


Qualifications
  • Successful graduation in a Life Science degree or equivalent
  • Proven expertise of medical device Regulatory Affairs on an international basis
  • Business development skill sets with exposure to or having worked in a regulatory consultancy model
  • Be able to demonstrate driving partnerships within the industry
  • Experience within a clinical trial program environment
  • Proven ability of interpreting legislation and impact to meet commercial needs
  • Proven capability of successful working relationships with regulatory bodies
  • Demonstrate an appreciation and understanding of the positive impact of regulatory in delivering business solutions
  • Excellent communication and interpersonal skills, ability to influence and motivate
  • Proven success at managing and driving a team to meet strategic goals and KPIs
  • Fluent German and English language skills (oral and written)

The well-being and development of our employees are central aspects of our company creed. Individuals who would like to fully realize their potential as part of our international, innovation-driven corporate family and who aspire to have challenging work, will find that our company provides just the right conditions. We consider intensive initial training, further education that is tailored to our employees' work and excellent opportunities for development - both nationally and internationally - to be just as essential as a good work-life balance, attractive compensation and above-average employee benefits. One aspect that distinguishes our company is the large number of measures we have to support our trainees and promote career development in ways that are also compatible with family life.



Primary Location
Germany-North Rhine Westphalia-Rhein-Kreis Neuss
Organization
Johnson & Johnson G.m.b.H. (7980)
Job Function
Regulatory Affairs
Requisition ID
1805621421W