Regulatory Affairs Specialist Healthcare

3 days ago

Reading, Reading, United Kingdom Bayer Full time

At Bayer, we're committed to creating a healthier world.

We're seeking a highly skilled Regulatory Affairs Manager to join our team in a role that will drive the life cycle management of medical devices, drug-device combinations, and digital health products.

As a key member of our regulatory intelligence cluster, you will prepare and maintain medical device technical files, lead post-market activities, and ensure compliance with global regulatory requirements.

Key responsibilities include:

  1. Developing and implementing regulatory strategies for the life cycle management of medical devices and drug-device combinations.
  2. Communicating regulatory strategies, risks, and key issues to project teams and stakeholders.
  3. Collaborating with product innovation and regulatory intelligence clusters to stay up-to-date on changes in regulations and standards.
  4. Ensuring compliance with global regulatory requirements and other relevant regulations.

Requirements include:

  • A degree in the life sciences, with a post-graduate degree preferred.
  • Relevant medical device & DDCs regulatory affairs experience in the pharmaceutical and/or medical device industry.
  • Experience with digital health solutions and software as a medical device, and their life-cycle management.
  • Strategic thinking and good business- and external trends insights.
  • Ability to communicate effectively in English, both verbally and in writing.

At Bayer, we offer a competitive compensation package, including an attractive base salary, annual bonus, and a range of benefits such as private healthcare, generous pension scheme, and life insurance.

We welcome and embrace diversity, and are committed to creating an inclusive working environment.

Bayer is an equal opportunities employer and welcomes applications from all individuals, regardless of age, disability, gender identity/expression, family status, pregnancy and maternity, race, religion or belief, sex, and sexual orientation.

We are committed to providing access and support for all individuals with disabilities and/or long-term conditions.

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