Expert Regulatory Intelligence (m/w/d)

Posted:
11/17/2024, 4:00:00 PM

Location(s):
Saarland, Germany ⋅ Bavaria, Germany ⋅ Sankt Wendel, Saarland, Germany

Experience Level(s):
Junior ⋅ Mid Level

Field(s):
Legal & Compliance

Fresenius Medical Care is the world’s leading provider of products and services by offering innovative products and treatment concepts of the highest quality. We continuously want to improve the quality of life for our dialysis patients, worldwide and every day.

Join our team and play a pivotal role in shaping the future of dialysis care, driving impactful innovations and strategies that enhance patient outcomes on a global scale!

Your responsibilities:

  • Collect, monitor, and communicate global regulatory requirements, including standards, laws, and guidelines, for product lifecycle, quality, and environmental management
  • Act as a liaison between country hubs, experts, business units, and central functions to gather and evaluate regulatory requirements
  • Initiate and manage gap analyses for new or updated regulations as the central point of contact
  • Administer standard management systems like Beuth eNorm and Techstreet, including licensing
  • Facilitate gap analyses and ensure follow-up actions are completed
  • Communicate regulatory updates and implement necessary measures
  • Support the creation of quality management system (QMS) inputs, such as management review materials
  • Help vertical teams compile lists of applicable standards, laws, and guidelines

Your profile:

  • Master’s degree in engineering, natural sciences, or a related field
  • 3+ years of experience in regulatory affairs, including monitoring regulatory requirements
  • Expertise in global regulatory requirements, including standards, laws, and guidelines across QMS and EHS
  • Strong project management skills and a structured, systematic approach
  • Familiarity with FME’s business and products is a plus
  • Excellent communication and stakeholder management skills, with the ability to explain complex topics clearly
  • Willingness to learn and adapt to new challenges
  • Fluent in business English

Our offer to you:

There is a lot for you to discover at Fresenius Medical Care, because we have a lot to offer. No matter in which field you are an expert and how much experience you bring with you - for your professional future with meaning:

  • The opportunity to work on a mobile basis
  • Whether in front of or behind the scenes - you will help to make better and better therapy available to more and more people around the world
  • Individual opportunities for self-determined career planning and professional development
  • A corporate culture in which there is enough room for innovative thinking - to find the best, not the fastest, solution together
  • A large number of committed people with a wide range of skills, talents and experience
  • The benefits of a successful global corporation with the collegial culture of a medium-sized company

Fresenius Medical Care North America

Website: https://fmcna.com/

Headquarter Location: Waltham, Massachusetts, United States

Employee Count: 10001+

Year Founded: 1996

Last Funding Type: Post-IPO Equity

Industries: Biotechnology ⋅ Health Care ⋅ Medical ⋅ Pharmaceutical