Job Description
Job title: Senior Regulatory Affairs Specialist – Regulatory Intelligence
Department: Regulatory Affairs
Location: Fareham, Hampshire or Remote
GLS: P3
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 Senior Regulatory Affairs Specialist within our Regulatory Intelligence team, you will provide global regulatory intelligence expertise, regulatory affairs, pre-clinical, clinical, and commercial areas for investigational and marketed products.
You will ensure that regulatory/competitive intelligence, or scientific/regulatory information searching, summarization, assessment and dissemination are provided to the business. You will also proactively monitor emerging external scientific and regulatory trends, approvals, and strategies to inform and influence the development of regulatory strategies and policies both across and within portfolio areas.
Essential Functions & Accountabilities:
- Develop and execute a regulatory intelligence strategy. Keep abreast of internal and external changes, trends, developments and other dynamics relevant to the regulatory environment that may have impact to the regulatory and access strategies and propose action plan.
- Understand and interpret complex scientific issues across projects and area(s) of responsibility as it relates to regulatory requirements, regulatory intelligence, policy and strategy for the region. Experience working with a major regulatory agency, specific experience in government affairs or policy is desired.
- Follow regulatory plans and interface with project team members, both within the organization and with a range of external groups, to drive corporate regulatory initiatives to completion.
- Liaise with internal functions such as quality assurance (QA) Operations, Operations, Manufacturing, Professional Services, Legal, RA, and Marketing to provide necessary information and documentation requested.
- Collect regional regulatory intelligence and provide monthly reports. Monitor impact of changing regulations on submission strategies and notify appropriate departmental personnel.
- Maintain regulatory files and documents in addition to internal regulatory tracking documents. This includes maintaining communication with supervisor and other departments to provide status reports.
- Assess applicability of documents of external origin (DOEOs) (i.e., standards, regulations, guidance) and maintain procedures associated with this process, including regulatory intelligence (RI).
- Prepare new/revised regulatory requirements for CooperVision site Management Reviews.
- Prepare MDSAP Chapter 2 data to CooperVision MDSAP sites in preparation for their audits.
A Full Job Description Is Available Upon Request.
About you:
We are looking for someone who has excellent collaboration and relationship building skills as well as influencing and negotiation skills as well as working knowledge of US regulations and guidance including but not limited to FDA 21 CFR, MDSAP, ISO 13485, UKCA, MedDO, MDD, and MDR.
Experience & Education:
Required
- 1-5 years of regulatory intelligence experience required.
- Actively develop an understanding of health authority inner workings, regulatory requirements, and potential interpretation of regulatory guidelines. Knowledge of regulations and guidance governing medical device in all phases of development, including post-marketing, in the US and/or EU, with a good understanding of basic regulatory requirements in emerging markets.
- Have familiarity with the database-oriented software and/or the Agile PLM (product lifecycle management)/global RA database reporting functions.
- Must be strong overall and able to train/develop staff in the area of regulatory intelligence such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory trends.
- Understand and interpret complex scientific issues across projects as it relates to regulatory requirements, regulatory intelligence, and strategy for the region.
- Bachelor’s Degree – Advanced scientific-related degree preferred;
What we offer:
You’ll receive competitive compensation and a fantastic benefits package including; 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 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
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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.
