Senior Scientist, Biocompatibility (Biological Evaluation)

CooperVision; Eastleigh; On-site; GBP 45,000 - 60,000; Full time

Job summary

CooperVision, a global leader in the contact lens industry, is seeking a Senior Scientist to focus on Biocompatibility and Biological Evaluation. This role involves preparing biocompatibility assessments, generating reports in compliance with EU MDR, and supporting cross-functional projects to ensure the safety of medical devices. Ideal candidates will have expertise in regulatory compliance and experience with ISO 10993 standards. Competitive compensation and benefits are provided.

Benefits

25 days holiday

Private medical insurance

Healthcare cover

Pension scheme

Life assurance

Qualifications

• Direct experience with ISO 10993 is essential.
• Industrial experience in medical device or pharmaceutical sectors preferred.
• Knowledge of international regulations affecting medical device compliance.

Responsibilities

• Compile and deliver biocompatibility assessments and reports.
• Perform risk assessments and gap analysis of regulatory documents.
• Collaborate with cross-functional teams on project requirements.

Skills

Stakeholder Engagement

Risk Assessment

Regulatory Compliance

Education

BSc in Biological Science or related discipline

MSc in Toxicology

Job description

Senior Scientist, Biocompatibility (Biological Evaluation)

Join to apply for the Senior Scientist, Biocompatibility (Biological Evaluation) role at CooperVision

Senior Scientist, Biocompatibility (Biological Evaluation)

Join to apply for the Senior Scientist, Biocompatibility (Biological Evaluation) role at CooperVision

Job Description

Job title: Senior Scientist, Biocompatibility (Biological Evaluation)

Job Description

Job title: Senior Scientist, Biocompatibility (Biological Evaluation)

Department: UK R&D Chemistry

Location: Chandlers Ford, Eastleigh

GLS: T03

Working hours: Monday to Friday 37.5 hours per week Onsite

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:

We have an exciting permanent opportunity for a Senior Scientist – Biocompatibility with a particular focus on Biological Evaluation. In this role, you will be responsible for generating, maintaining, and updating Biological Evaluation Reports (BERs) per EU MDR requirements. The role focusses on the toxicological and biocompatibility evaluation of products and technologies required for product approvals and the establishment of patient safety of medical devices in accordance with applicable global regulatory guidelines.

Additionally, the senior scientist will provide support to enable the delivery of toxicological risk assessments for different projects, process change assessments, material quality assessments including material supplier contamination, innovation projects and support to regulatory projects.

Key responsibilities include:

• Compile and deliver biocompatibility assessments and biocompatibility evaluation plans and reports in compliance with applicable biological evaluation standards and guidance documents.
• Generation and maintenance of Biological Evaluation Reports to meet EU MDR regulations.
• Perform and assist with risk assessments and gap analysis of external standards, regulatory requirements, and guidance documents associated with biological safety evaluation.
• Collaborate with cross-functional teams to support projects requiring biocompatibility evaluation and ensure timely completion to meet established deadlines.
• Keep abreast of regulatory requirements including monitoring EU MDR, FDA and other agency regulations and international standards with respect to biological evaluation.
• Prepare or collaborate in the preparation of toxicological safety assessments including materials, chemicals, technologies and processes or finished products.
• Work within multi-disciplinary teams (notably R&D, HS&E, Import/Export, Supply Chain and RA/QA) on a variety of activities as required by the business.
• Ensure due process is followed under R&D Policies and Framework.
• Support the creation and development of the strategy for biological/toxicological evaluation (including testing requirements) for materials and finished products.
• Provide technical support and coaching for members of R&D, regulatory or any other relevant department.
• Provide consultancy on technical issues both within R&D and other stakeholders.
  
  
  

A Full Job Description Is Available Upon Request.

About you:

We are looking for someone who is a strong team player with good stakeholder engagement skills who can bring with them the following experience:

• Either a BSc in a biological science (Pharmacology, Biology, Physiology, Biochemistry or similar) or related discipline (MSc in Toxicology or any work-related experience in toxicology a bonus)
• Industrial experience within the chemical area (Medical device / pharmaceutical preferred) depending on degree level
• Direct experience working with ISO 10993 is essential.
• Demonstrated success in leading change in particular for the implementation of ISO 10993 standards series is essential.
• Working knowledge of domestic and international regulations and standards that affect Class II and III medical device compliance is essential.
  
  
  

What we offer:

You’ll receive competitive compensation and a fantastic benefits package including 25 days holiday, Private medical insurance, 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 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.

Please view our careers page at https://hcjy.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/CX_1 to view all other opportunities.

Qualifications

#INDHP

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 an 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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Medical Equipment Manufacturing

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