Quality & Regulatory Compliance Specialist
CooperCompanies
Hamble-le-Rice SO31, UK
Published 1 week ago
Compliance Management Systems / Technology
Job Description
Job title: Quality & Regulatory Compliance Specialist
Department: Quality
Location: Hamble
GLS: PO2
Working hours: 37.5 Hours
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 Quality & Regulatory Compliance Specialist of our RA/QA, you will be responsible for providing ongoing and up-to-date quality and regulatory information, advice and guidance for change and risk management to our UK Manufacturing and Distribution teams.
Working with a team of 3 reporting directly to our Quality Systems & Regulatory Compliance Manager, you will be responsible for ensuring a consistent, effective, and compliant approach across our teams and will actively participate in compliance activities (audits).
Role Responsibilities:
Frequent travel to other UK Sites will be required, with less than 5% of foreign travel.
A full job description is available upon request.
About you:
We are looking for someone who has at least two years' experience in a similar Medical Device/Regulatory/Quality Systems environment and has excellent written and verbal communication skills, demonstrating diplomacy, patience and approachability while working alongside a broad range of colleagues.
Experience & Education:
You'll receive competitive compensation and a fantastic benefits package including; 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/… view all other opportunities.
#INDHP
#LI-ONSITE #LI-LD2
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.
Job title: Quality & Regulatory Compliance Specialist
Department: Quality
Location: Hamble
GLS: PO2
Working hours: 37.5 Hours
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 Quality & Regulatory Compliance Specialist of our RA/QA, you will be responsible for providing ongoing and up-to-date quality and regulatory information, advice and guidance for change and risk management to our UK Manufacturing and Distribution teams.
Working with a team of 3 reporting directly to our Quality Systems & Regulatory Compliance Manager, you will be responsible for ensuring a consistent, effective, and compliant approach across our teams and will actively participate in compliance activities (audits).
Role Responsibilities:
- Reviewer of Engineering Change Order's (ECO) on local and multi-site ECOs for UK Manufacturing, UK Packaging & Distribution and Labelling & Packaging and Liege and accountable for providing accurate guidance to change leaders within the UK Manufacturing, Packaging & Distribution to ensure compliance with respective quality and regulatory requirements.
- Prepare timely and accurate ongoing and periodic data required to support Global Regulatory Affairs in the preparation of compliance reports and submissions to the FDA on behalf of UK Manufacturing, Packaging & Distribution.
- Prepare/review content of QA Training Courses (Regulatory Awareness, ECO and Risk Management) to ensure ongoing accuracy.
- Prepare and maintain a Risk Management Review schedule for UK Manufacturing, Packaging & Distribution.
- Perform administrative tasks in support of product compliance/CE Marking with CooperVision's Notified Body (NB).
Frequent travel to other UK Sites will be required, with less than 5% of foreign travel.
A full job description is available upon request.
About you:
We are looking for someone who has at least two years' experience in a similar Medical Device/Regulatory/Quality Systems environment and has excellent written and verbal communication skills, demonstrating diplomacy, patience and approachability while working alongside a broad range of colleagues.
Experience & Education:
- Educated to degree level and/or relevant experience in a medical device/regulatory environment.
- Understanding of ISO 13485 requirements and EU/FDA medical device regulations.
- Ability to read and understand technical material.
- Flexibility to work across the UK sites, with occasional global travel.
You'll receive competitive compensation and a fantastic benefits package including; 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/… view all other opportunities.
#INDHP
#LI-ONSITE #LI-LD2
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.