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Regulatory Life Cycle Manager- Non Medicinal

Bayer SAS, Reading

Regulatory Life Cycle Manager- Non Medicinal

Salary Not Specified

Bayer SAS, Reading

  • Full time
  • Permanent
  • Remote working

Posted today, 1 Nov | Get your application in now to be one of the first to apply.

Closing date: Closing date not specified

job Ref: 75c5438ef04040caa6915d6973710abf

Full Job Description

  • Prepare and maintain medical devices technical files and lead post-market activities such as variations, renewals, and annual reports.
  • Develop and implement regulatory strategies for the life cycle management of medical devices, Drug-Device Combination products, and digital health products.
  • Proactively communicate regulatory strategies, risks, and key issues throughout the life cycle to project teams and other stakeholders.
  • Ensure compliance with global regulatory requirements, and other relevant regulations.
  • Collaborate with Product Innovation and Regulatory Intelligence Clusters, stay abreast of changes in regulations and standards, and communicate potential impact to the organization.
  • Provide support for internal and external audits.

    A degree in the life sciences (post-graduate degree is preferred but not required).
  • Relevant medical device & DDCs regulatory affairs experience, in the pharmaceutical and/or medical device industry (MDD, MDR, UKCA).
  • Experience with Digital Health Solutions and Software as a Medical Device (SaMD) and their life-cycle management is highly desirable.
  • Pro-actively asks for and gives feedback.
  • Demonstrates strategic thinking as well as good business- and external trends insights.
  • Collaborates with accountability: collaborates and holds each other accountable in and across teams.
  • Co-creates for customers: is close to the customer and co-creates solutions for their needs.
  • Acts, learns fast and evolves: works in 90-days cycles, applies learnings fast and continually develops.
  • Creates impact by realizing authentic self and purpose, and includes others: respects differences, embraces inclusion and shows up as the best self.
  • Proficiency in MS Office: Word, Excel, PowerPoint
  • Ability to communicate effectively in English both verbally and in writing.

    At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice., "At Bayer, sustainability is ingrained in our mission 'Health for all, hunger for none', driving our commitment to healthcare and agricultural innovation. We prioritise reducing our environmental footprint, enhancing our social impact, and ensuring sustainable business practices. As part of our team, you'll have opportunities to contribute to various initiatives such as achieving climate neutrality across our facilities by 2030, to improving access to healthcare and nutrition to 100 million underserved people worldwide by 2030. Join us and be part of a culture that values innovation and empowers change, as we strive to shape a healthier, more sustainable, and inclusive world."

    Competitive compensation package consisting of an attractive base salary and annual bonus. Individual bonus can also be granted for top performance awards.
  • 28 days annual leave plus bank holidays
  • Private Healthcare, generous pension scheme and Life Insurance
  • Wellness programs and support
  • Employee discount scheme
  • State of the art offices
  • International career possibilities
  • Flexible and and Hybrid working
  • Help with home office equipment
  • Volunteering days
  • Support for professional growth in a wide range of learning and development opportunities
  • We welcome and embrace diversity providing an inclusive working environment
    • The best possible work-life balance is of great importance to us, which is why we support flexible hybrid working model.

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