Director of Regulatory Affairs and Compliance EMEA

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Location: Basingstoke, UK
Job Category: Quality & Regulatory Affairs
Position Description
Director of Regulatory Affairs and Compliance EMEA

We are looking for a proven leader who will foster growth and innovation as we achieve our goal of becoming the leading respiratory company in the world.

As the Director of Regulatory Affairs & Compliance, you will report directly to the Vice President of Regulatory Affairs and have a hands-on role in defining, deploying, and leading organizational, process, and product quality requirements that directly impact multiple facilities and across the product life cycle.

In particular, you can expect to:

  • Drive change and innovation by providing thought leadership and nurturing a culture of improvement and excellence.
  • Lead, empower, and motivate highly effective QRA teams through mentorship and coaching – developing them professionally and to grow business.
  • Ensure effective implementation of Quality Systems and Compliance requirements per corporate policies and local regulations – continuously looking for ways to innovate process to drive business results.
  • Work with government authorities regarding quality, regulatory and compliance issues.
  • Monitor the activities of government regulatory authorities, globally, to ensure business is able to align with, comply with, and anticipate changes.
  • Implement a Corporate Compliance program and manage post-market surveillance program per EMEAI local regulatory requirements – looking for opportunities to enhance the process.
  • Develop productive relationship with internal partners to ensure compliance with regulatory requirements and provide support and thought leadership across the business.
  • Prepare, present, defend, and manage the departmental budget and staff.

You will have the opportunity to:

  • Improve patient outcomes
  • Meaningfully impact the company’s short-term and long-term success
  • Work closely with executives across the organization
  • Grow your role as you see fit
  • Learn about respiratory medical device manufacturing
  • Create an inspiring and productive workplace

To be successful, you will need:

  • 10 years of related experience in the medical device, pharmaceutical, and/or medical diagnostics industry, with at least 5 years of management experience.
  • A dynamic change agent with the ability to analyze situations and implement solutions that drive strategy forward.
  • Proven experience driving significant improvements with a team and business.
  • Experience working in a global environment and leading multi-site enterprise level teams.
  • Demonstrable experience building teams that create strategic change within the business.
  • High energy, results-oriented leader with excellent collaboration and project management skills.
  • Ability to make sound judgment in technical, business, and regulatory compliance arenas, with strong expertise of domestic and international regulatory compliance requirements.
  • Proven experience and knowledge in product submissions and PMS program per EMEAI regulations.
  • Experience leading internal audit programs and managing external inspections/audits (e.g. FDA, Competent Authorities, and Notified Bodies).
  • Effectively work with Corporate and platform QA and Regulatory Affairs partners.
  • Experience dealing with government regulatory bodies, Competent Authorities, and Notified Bodies.

Education:

  • Bachelor of Science degree engineering or a scientific or technical discipline.
  • Master of Science degree engineering or a scientific or technical discipline preferred.
  • Six Sigma Black Belt or Master Black Belt strongly desired.
  • Certified Quality Auditor and/or Manager or equivalent desired.
  • Ability to speak multi-languages is desired.

Some logistics:

  • Based in Basingstoke, UK.
  • Travel required up to 40%, including international.

Basingstoke

Full time
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