Job Description
Job title: Principal Regulatory Affairs Specialist
Department: Regulatory Affairs
Location: Remote
GLS: PP4
Working hours: 37.5 [DS1] 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 a Principal Regulatory Affairs Specialist, you will be expected to provide expert level regulatory support at two of our specialist sites based in the UK and Netherlands.
You will be expected to give support to regulatory affairs activities at expert level providing guidance and direction to products from concept to launch, and beyond into post market as well as taking ownership for regulatory processes.
The Principal Regulatory Affairs Specialist will articulate and execute the agreed regulatory strategy for several internal projects acting as a core member of the team which will require you to lead the creation, development, and implementation of regulatory affair procedures for marketed products and to maintain, update or remediate CooperVision’s regulatory compliance status.
Essential Functions & Accountabilities:
- Registration Activity
- Reviews and approves regulatory documents for the registration of current and new products in assigned markets.
- Oversees the maintenance of submission documents, and QMS and regulatory databases in an accurate, complete and timely manner to ensure prompt and accurate access to company regulatory information.
- Maintains, updates and remediates regulatory files and documents as required. This includes maintaining communication with the Global Specialty RA Management and, as necessary, the EMEA RA team and other departments, sites, or business units, to provide regulatory status reports.
- Monitoring Registration Requirements within Region
- Maintains up-to-date knowledge of regional and national regulations, guidelines, and advisory documents required for marketing CooperVision products in a specified region.
- Communicates applicable regulatory requirements to CooperVision Regulatory Affairs management and business partners.
- Analyses impact and communicates to management changes in regulations or requirements that have been identified.
- Establish and leverage working relationships with government, regulatory agencies, and trade associations for the purpose of advocating CooperVision positions
- Technical Documentation
- Prepares and reviews compiled Technical Files for CE approval prior to submission.
- Supports RA Management with Notified Body requests for information.
- As required, plays a significant role in technical audits in the UK, EU, ACE and MENA region, i.e. preparation, contingency planning, response, findings and close out activities.
- Support to CooperVision Processes
- Represents the perspective of regulatory affairs to the company.
- Interprets general business objectives and effectively present information to manager and regions.
- Reviews and approves product labelling. Initiates IFUs and other required product labelling in line with relevant UK, EU, ACE & MENA requirements.
- Supports “Own Brand” and “Private label “ customers and liaises with EU Competent Authorities and other Ministries of health as necessary.
- Provides input to Regulatory Affairs Impact Documents (RAIDS) from a UK, EU, ACE & MENA perspective.
- Undertakes other administrative tasks to support CE marking and regional registrations.
- Responsible for exhibiting professional behaviour with internal and external business associates that reflects positively on CooperVision, The individual conveys a trustworthy, credible, and reliable image at all times.
- Act as a resource to the regions on quality issues and propose changes to minimise risks and enhance quality, reliability, safety and productivity.
- Act as spokesperson, when appropriate, regarding CooperVision practices, public policy, business interests; arrange for technical explanations from internal or external experts.
- Support RA compliance activities as necessary in assigned regions.
A Full Job Description Is Available Upon Request.
About you:
We are looking for someone who has proven experience in building relationships across a diverse business, and the capability to interact effectively and credibly at senior levels. Experience in electronical document management systems is required as well as the ability to read and understand technical material.
Experience & Education:
- Bachelor’s degree in a scientific or technical discipline and working knowledge of medical device regulations
- 6-8 years of medical device regulatory experience
- Understanding of ISO 13485 requirements and EU medical device regulations
- Medical device industry experience including strong working knowledge and experience with MDD and MDR
- Technical writing experience. Has experience evaluating manufacturing changes for impact on global regulatory affairs submissions
- Experienced at reviewing and approving product labelling
- 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
What we offer:
You’ll receive competitive compensation and a fantastic benefits package including; bonus, private medical insurance, 25 days holiday, pension scheme, healthcare cover, life assurance [DS2] , 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 your 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 quoting the job reference code to enjoy a £100 voucher reward if they are successful!
Please view our careers page athttps://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.
