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