Senior Regulatory Affairs Specialist, Global Regulatory Systems

Job Description

JOB TITLE : Senior Regulatory Affairs Specialist, Global Regulatory Systems **

LOCATION : Delta Park, Segensworth

WORKING HOURS : Monday – Friday. 0830 – 1630 (Hybrid/Remote depending on business need)

A brighter future awaits you**

At CooperVision, we are proud to be the global leader in contact lenses. At our innovative sites worldwide, we manufacture and distribute contact lenses to some of the biggest names in optics. We’re all about creating brighter futures for our customers, our wearers and our people. **

What can you expect from us as an employer?**

Well, we like to look at things a little differently. We call it bringing a refreshing perspective. And for every one of us who works here, it means our opinion really counts, we get to share our ideas, and we get to make an impact.

We’re big on belonging. Because being part of something great is what makes our company the best it can be. And we value diversity, because you can see a whole lot more when you have different perspectives. We’re an ambitious company. And to help us achieve our goals, we’ll give you all you need to achieve yours. **

What will you be doing?**

The Senior Regulatory Affairs Specialist, Global Regulatory Systems will provide support and direction to Regulatory Affairs team members responsible for utilising our systems. This will include the Veeva Vault RIM Suite (RIM system) to allow us to achieve global product registrations and other regulatory activities, helping to ensure that our systems are consistently utilised across the teams.

You will also be expected to work with our Regulatory Affair colleagues to troubleshoot and resolve issues with using regulatory systems, ensuring appropriate integration with other CooperVision systems such as the eQMS platform, Agile.

Keeping consistent with the corporate values and quality policy and procedures, you will also be responsible for exhibiting and demonstrating professional integrity and collaboration with internal and external business associates that reflects positively on CooperVision. **

Responsibilities**

• Supports the implementation and improvement of regulatory affairs processes, including systems relating to the Regulatory Information Management (RIM) system, the availability of technical documentation in support of global product submissions and registrations, and Unique Device Identification (UDI) management.
• Liaises with third-party system vendors as appropriate, including following related Supplier Quality processes.
• Supports the development of procedures and training on regulatory systems.
• Liaises across the Regulatory Affairs function to ensure that adequate training and support is given to Regulatory Affairs team members on regulatory systems.
• Liaises across the Regulatory Affairs function to ensure that adequate training and support is given to Regulatory Affairs team members on QMS processes as appropriate.
• Works with regional teams to identify and propose improvements to regulatory systems, including how the system interfaces with other systems such as the eQMS.
• Works closely with the RIM system and other system administrator teams to support changes and improvements required.
• Liaises with other, non-RA internal functions to assist with ensuring that all documentation required to support global product registration activities is adequately embedded in the QMS and is available in the RIM system for end users.
• Monitors the use of the RIM system, supporting the regional teams with the completion of activities relating to global product registrations.
• Monitors the use of other regulatory systems as necessary.
• Supports the development of metrics relating to use and performance of the RIM system and other regulatory systems.
• Supports the investigation into issues identified with or through regulatory systems, liaising across functions as required and utilising QMS processes as appropriate.
• Maintains comprehensive, audit-ready records of activities as required by the QMS.

Qualifications

What are we looking for?

We would like you to have the following experience:

• 3-6 years of medical device experience in a regulatory role, familiar with regulatory systems.
• Technical writing experience. Has experience evaluating manufacturing changes for impact on global regulatory affairs submissions.
• Understanding of ISO 13485 requirements and EU medical device regulations
• Knowledge of QMS improvement and management processes
• Strong working knowledge and experience with MDD and MDR.
• Ability to operate in a business driven model providing quick, salient analysis and concrete action plans emphasis on understanding and anticipating business needs and interests and devising proactive approaches/responses.
• Must have the ability to build relationships and influence decision makers.
• Comprehension of industry developments and changes in the political environment.
• Extensive network-building and contact experience.
• Capability to interact effectively and credibly at senior levels.
• Experience in electronic document management systems
• Strong IT skills, problem solving ability, analytical and communication skills.
• Flexibility to work across the UK sites

Travel Requirements:

Position may require occasional (5%) local or international travel to CooperVision facilities, government agencies, Customers, trade shows or training courses.

Work Environment:

• Office/Hybrid/Remote environment.
• Prolonged use of a computer.

What do we offer?

You’ll receive competitive compensation and a fantastic benefits package including; 25 days holiday, private Medical, 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!

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. **

What is important to us?**

Our four values define and underpin our unique culture; we are dedicated, we are inventive, we are friendly, and we are partners. Becoming part of the CooperVision family means joining a friendly team that’s open, flexible, and respectful of each other’s differences, working together to achieve something amazing.

Recruiting, retaining, and promoting a diverse mix of employees is core to our success. It helps bring different perspectives, diverse conversations, and new ideas to the table, all of which are incredibly valuable.

At CooperVision we celebrate, not only our company success, but we celebrate who we all are individually, and we embrace diversity. We support and we encourage you to bring your full self and not just part of you. We are committed to each individual and we look forward to a Brighter Future together. **

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.