Regulatory Affairs Director
4 weeks ago
Adecco is working with a highly successful Medical Device manufacturer in Stoke.
The business has had a lot of success and with that comes the need to expand and grow.
That is why a newly created role of Regulatory Director has been introduced.
Experience needed for this role includes:
- Extensive knowledge of requirements and processes for EU and US regulatory approval of medical devices.
- Implementation of regulatory systems and assuring compliance to all applicable regulations.
- Proven track record of success in problem-solving and developing risk-based solutions.
- Prior responsibility for FDA submissions, registrations, complaint review for reportability, and generating/submitting agency reports (i.e., MDRs, Vigilance, etc.)
- Understanding of global regulatory, government affairs, and legal liability issues, FDA QSR, and ISO 13485 required.
- Well-developed cross-functional project and team management skills.
- Strong leadership and demonstrated experience in interfacing and working with external partners, regulatory agencies, including FDA.
**Personal Requirements**
- Excellent verbal and written communications skills and the ability to convey complex regulatory requirements in a straightforward and practical manner.
- Passionate leader, enthusiastic and able to inspire others to drive results while helping members at all sites feel competent, challenged, and supported a strong sense of ethics and a commitment to uncompromising integrity.
- Ability to work well cross-functionally, and in team settings and independently, take a stand and ensure completion of time-critical projects.
- Strategic thinker, with ability to find novel solutions to complex business challenges.
- Structured and well organized.
- Confident and out-going personality with excellent influencing skills.
- Good business acumen, pragmatic and business oriented.
- Able to identify and focus on the key priorities.
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