Job Board

Companies

Convatec

Biocompatibility Specialist II

London Full-Time 36000 - 60000 £ / year (est.) Home office (partial)

Apply now

At a Glance

Tasks: Join us as a Biocompatibility Specialist II, ensuring compliance with ISO standards and evaluating medical devices.
Company: Convatec is a global leader in medical solutions, dedicated to improving lives through innovative products.
Benefits: Enjoy remote work options, a supportive culture, and the chance to make a real impact.
Why this job: Be part of a mission-driven team focused on excellence and transforming healthcare for millions.
Qualifications: A degree in Biomedical Engineering or related fields, plus 3 years of relevant experience required.
Other info: This role may involve occasional travel and offers a dynamic, collaborative work environment.

The predicted salary is between 36000 - 60000 £ per year.

Social network you want to login/join with:

Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Group revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit
At Convatec, we’re transforming our business for the better. Better products. Better ways of working. And better ways of delivering for our customers and each other. We’re aiming for nothing short of excellence. Join us on our journey to #ForeverCaring as a Biocompatibility Specialist II, and you’ll do the same.

About the role:

Works within prescribed ISO 10993 Standards and ensures specific compliance to all national and international regulations relevant to Biocompatibility. Function as a Subject Matter Expert (SME) in biocompatibility at Convatec supporting Global Operations and Supply in evaluating established device, material, and process changes through the change control process either with Safety Assessments or updates to existing biological evaluations of existing products and associated processes. Support projects/programs in terms of biocompatibility of medical devices, materials, and processes. This role will work closely with program/project cross-functional teams to provide biocompatibility deliverables in compliance with global regulatory and internal requirements.

Your key duties and responsibilities:

Manage and oversee the SME role for Biocompatibility for impacts to devices relating to changes managed through Change Control (CCRs) and new product development projects within Convatec.

Mentor the biocompatibility team of SMEs through project assignment and technical reviewing.

Investigate and evaluate risk to patients with unintended contamination or processes within a Safety Assessment.

Develop or revise biological evaluation protocols, reports, and regulatory summaries in collaboration with cross-functional program teams, test laboratories, and suppliers.

Understand biocompatibility strategies that are formed in consideration of product and process changes, gaps in materials, design and process to achieve optimal solutions that satisfy cost and technical requirements as they relate to biological safety.

Evaluate and execute biocompatibility studies, conducted by external laboratories, in support of programs dealing with our medical devices.

Make positive contributions to recommend approaches to, and support updating/ developing procedures for internal and external guidance document as they relate to biocompatibility, in compliance with applicable global regulatory requirements ( FDA, ISO, MHLW, and CFDA).

Support biological hazards risk analysis activities.

Interface with and indirectly report to corporate biocompatibility team and represent biocompatibility on project/program teams.

Analyze, interpret, and draw conclusions from biocompatibility testing, including, but not limited to, extractable and leachable, chemical characterization and biological evaluations

Participate in industry related standard committees, conferences, and scientific communities as appropriate and able to.

Skills & Experience:

Fundamental understanding or direct experience of the ISO 10993 standards, toxicological assessment, extractable and leachable analysis, medical device manufacturing processes, and biocompatibility assessment methodology

Basic knowledge of FDA and international medical device regulations/directives and working knowledge of GMP/ISO/GLP guidelines as applied to medical device testing and documentation.

Have the ability to work with people and teams in a complex, changing environment and be able to deliver value added results to the business on time.

Be fully competent in oral and written communications including strong documentation skills.

Ability to collaborate across multiple internal disciplines and global cultures.

Solid technical writing that is business friendly to support robust conclusions and submissions to authorities.

Ability to define, document, and communicate standard operating procedures designed for compliance, accuracy, efficiency, and simplicity.

Qualifications/Education:

BS in one or more of the following disciplines: Biomedical Engineering, Bioengineering, Biology (Biological Sciences), Molecular Cell Biology, Biochemistry, Materials Science, or Toxicology; advanced degree (MS or PhD) in these fields preferred.

+3 years related to biocompatibility evaluations and/or toxicological risk assessments of medical devices.

Fundamental understanding or direct experience of the ISO 10993 standards, biomaterials, toxicological assessment, extractable and leachable analysis, medical device manufacturing processes, and biocompatibility assessment methodology.

Capable of developing and driving to a detailed project plan with scheduled and defined dependencies between tasks and deliverable.

Travel Requirements:

The position may involve occasional travel up to 5-15%, both domestically and overseas. Most trips will include overnight travel.

Working Conditions:

This role may be based in the UK with a remote working structure.

May need to support global discussions in different time zones.

Our ambitions will bring the very best out in you. You’ll be pushed to aim higher and really own your work. You’ll be encouraged and supported to make things happen, too. It can be challenging. But, as the progress you make will help improve the lives of millions, it’ll be worth it.

This is stepping up to a challenge.

This is work that’ll move you.

#LI-DS4

#LI-Remote

Beware of scams online or from individuals claiming to represent Convatec

A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.

If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you’re unsure, please contact us at .

Equal opportunities

Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.

Please note that if you are NOT a passport holder of the country for the vacancy you might need a work permit. Check our Blog for more information.

Bank or payment details should not be provided when applying for a job. Eurojobs.com is not responsible for any external website content. All applications should be made via the \’Apply now\’ button.

Created on 02/07/2025 by TN United Kingdom

#J-18808-Ljbffr

Biocompatibility Specialist II employer: Convatec

At Convatec, we pride ourselves on being a leading global medical products company that is dedicated to improving lives through innovative solutions. Our collaborative work culture fosters personal and professional growth, offering employees the chance to make meaningful contributions while working alongside passionate colleagues in a supportive environment. With a commitment to excellence and a focus on employee development, Convatec provides a unique opportunity for Biocompatibility Specialists to thrive in a role that directly impacts patient outcomes across the globe.

Contact Detail:

Convatec Recruiting Team

View Convatec Profile

StudySmarter Expert Advice 🤫

We think this is how you could land Biocompatibility Specialist II

✨Tip Number 1

Familiarise yourself with ISO 10993 standards and the specific biocompatibility requirements for medical devices. Understanding these regulations will not only help you in interviews but also demonstrate your commitment to compliance and safety.

✨Tip Number 2

Network with professionals in the biocompatibility field, especially those who have experience with Convatec or similar companies. Engaging in industry-related forums or attending conferences can provide valuable insights and connections that may lead to job opportunities.

✨Tip Number 3

Prepare to discuss your experience with toxicological assessments and biocompatibility evaluations during interviews. Be ready to share specific examples of how you've contributed to projects or solved problems related to these areas.

✨Tip Number 4

Showcase your ability to work collaboratively across different teams and cultures. Highlight any past experiences where you successfully navigated complex environments, as this is crucial for the role at Convatec.

We think you need these skills to ace Biocompatibility Specialist II

ISO 10993 Standards Knowledge

Toxicological Assessment

Extractable and Leachable Analysis

Biocompatibility Assessment Methodology

Medical Device Manufacturing Processes

Regulatory Compliance (FDA, ISO, MHLW, CFDA)

Good Manufacturing Practice (GMP)

Good Laboratory Practice (GLP)

Technical Writing Skills

Project Management

Risk Analysis

Cross-Functional Collaboration

Strong Communication Skills

Problem-Solving Skills

Mentoring and Leadership

Some tips for your application 🫡

Understand the Role: Before applying, make sure you thoroughly understand the responsibilities and requirements of the Biocompatibility Specialist II position. Familiarise yourself with ISO 10993 standards and the specific biocompatibility tasks mentioned in the job description.

Tailor Your CV: Customise your CV to highlight relevant experience in biocompatibility evaluations, toxicological assessments, and any direct experience with medical device regulations. Use keywords from the job description to ensure your CV aligns with what Convatec is looking for.

Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also demonstrates your passion for improving patient outcomes through biocompatibility. Mention specific projects or experiences that relate to the role and how they have prepared you for this position.

Proofread and Edit: Before submitting your application, carefully proofread your documents for any spelling or grammatical errors. Ensure that your writing is clear and professional, as strong documentation skills are essential for this role.

How to prepare for a job interview at Convatec

✨Understand ISO 10993 Standards

Make sure you have a solid grasp of the ISO 10993 standards, as this role heavily relies on them. Be prepared to discuss how these standards apply to biocompatibility and any relevant experiences you've had in your previous roles.

✨Showcase Your Technical Writing Skills

Since strong documentation skills are crucial for this position, bring examples of your technical writing. Whether it's reports, protocols, or regulatory summaries, demonstrating your ability to communicate complex information clearly will impress the interviewers.

✨Prepare for Cross-Functional Collaboration

This role involves working closely with various teams. Be ready to share examples of how you've successfully collaborated across different disciplines in the past, highlighting your ability to navigate complex environments and deliver results.

✨Discuss Risk Assessment Experience

Given the focus on safety assessments and risk analysis, prepare to talk about your experience in evaluating risks related to biocompatibility. Share specific instances where you identified potential hazards and how you addressed them.

Biocompatibility Specialist II

London

Full-Time

36000 - 60000 £ / year (est.)

Apply now

Application deadline: 2027-07-12
Convatec

View Convatec Profile

Similar positions in other companies

UK’s top job board for Gen Z

Discover now