Job Description
Job title: Director, Regulatory Affairs (EMEA)
Department: EMEA Regulatory
Location: Delta Park, Segensworth
GLS: M5
Working hours: 37.5 Hours Weekly
A brighter future awaits you
CooperVision is one of the world’s leading manufacturers of soft contact lenses with a presence in over 100 countries. Being part of CooperVision means helping improve the way people see each day. It’s more than making contact lenses, it’s about giving lens wearers freedom and confidence to move about their daily lives. We’re all about bright futures – for our people and those who wear our contact lenses.
At CooperVision, we’re big on belonging. Everyone’s contribution counts, and that’s why inclusion and diversity are so important.It isn’t just the right thing to do; it’s what makes our company the best it can be. We are committed to creating an inclusive and engaging workplace. Our Employee Resource Groups offer employees to grow within a safe and inclusive space. So be yourself, whoever you are, and let’s achieve amazing things together.
Job summary – What to expect:
As the Director of Regulatory Affairs EMEA, you will be responsible for leading, developing and implementing partnership strategies for regulatory approvals to support business plans.
As a subject matter expert, you will be expected to use your expertise to translate regulatory requirements into practical, innovative, workable, solutions-oriented plans via interacting directly with regulatory agencies and the implementation of the CVI Global QMS.
You will also ensure timely preparation of organized and scientifically valid submissions, providing expertise in translating regulatory requirements into practical, workable plans and interacts with regulatory agencies, R&D, Marketing, supply chain, and the regional RA staff within the business.
Within this position, you will have two direct reports (Senior Managers) and approximately 8 indirect reports. The teams are split between management of EU, UK and CH with the second team managing CIS, ACE and MENA regions.
This position leads against the RA Mission Statement:
PROTECT the Business;
GROW the Business. We will engage as trusted and strategic business partners, delivering pragmatic solutions and creative regulatory strategies to:
- PROTECT the business and our freedom to operate.
- GROW the business and create real advantages for customers and wearers.
A Full Job Description Is Available Upon Request.
About you:
We are looking for someone who has in-depth knowledge of EU MDR as well as strong working knowledge of EMEA Medical Device regulations.
Experience & Education:
Required
- Bachelor’s Degree (B.A.) required. M.S. or higher degree preferred.
- In-depth knowledge of the EU MDR.
- Working knowledge of EMEA Medical Devices regulations.
- Experience in Quality Management Systems, ISO13485 and MDSAP.
- A proven track record in the management of regulatory compliance processes, recall, Adverse Event Reporting.
- Ability to read and understand highly technical material and interpret regulations. Ability to work under pressure and adhere to deadlines.
- Strong knowledge of international business, regulatory environments, regulations and legal product registration processes is required, as well as proficient product knowledge acquired through experience. Strong computer skills, problem solving ability, analytical and communication skills.
- Significant experience in Medical Devices Regulatory Affairs
- Required 8 years in a leadership role working across multiple countries, languages and cultures.
Preferred
- Experience working in the Optical industry, specifically contact lenses is a plus.
Travel Requirements:
- 30% within the EMEA region and globally to CooperVision offices.
Work Environment:
- This is a hybrid office based role, based at the CooperVision site near Southampton, Hampshire (PO15 5RL).
- Relocation support will be considered within UK
What we offer:
You’ll receive competitive compensation and a fantastic benefits package including; car allowance, bonus, family private medical insurance, 25 days holiday, pension scheme, healthcare cover, life assurance, access to our Wellness Platform to support you in mental health and wellbeing, a discounted contact lens scheme and much more!
We are committed to our employees’ personal and professional development and offer extensive training to support your career growth and help every individual to reach their full potential. To help us achieve our goals, we’ll give you everything you need to help you achieve yours.
We also provide access to LinkedIn Learning to help you develop in you career and grow with CooperVision
What you can expect:
As a CooperVision employee, you’ll be welcomed into a diverse and progressive global business. We appreciate how important fostering a diverse and inclusive culture is and how different perspectives add value and contribute to our success. With our CooperPride, African Descent, Woman’s Impact Network and Mind Body and Wellbeing Employee Resource Groups, we offer opportunities for employees to learn and grow within an inclusive and safe space.
If you like what you see, take the first step towards your Brighter Future and apply today! All suitably qualified applicants will receive equal consideration and opportunities from CooperVision.
We operate a candidate referral scheme, so if you know anyone who could be a perfect fit for this role, please email their CV to referafriend@coopervision.co.uk quoting the job reference code to enjoy a £100 voucher reward if they are successful!
Please view our careers page at https://hcjy.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/CX_1
to view all other opportunities.
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About Us
CooperVision is a global leader in the contact lens industry, dedicated to helping improve the way people see every day. Achieving that goal takes the collaboration of team members with wide-ranging skills; from scientists and researchers, to manufacturing and operations experts, to sales and marketing professionals.
At CooperVision, our effort to improve lives begins with our employees. We are committed to developing people as a key global differentiator and our most important asset. We empower employees to succeed, rewarding great thinking and hard work with competitive pay, comprehensive benefits, and with a special focus on wellness. Our commitment to our core values and a diverse, inclusive, employee-centric culture fuel a deeply engaged, high performing organization.
CooperVision employees pride themselves on being proactive, innovative, flexible and friendly. That’s a strong reflection of our corporate culture—and part of the reason CooperVision may be a great workplace for you.
