Regulatory Affairs Director

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.

The ideal candidate will have 6-8 years of experience in regulatory affairs, including minimum 3 years in a team leadership role.

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 (ie, 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.

If the role could be of interest, please apply and we can talk in more detail.