We are seeking a Biological Safety Specialist to join our Biological Compliance team. This role plays a key part in ensuring the ongoing regulatory compliance of the Biological Safety Evaluation programme across all Corin products.
You will collaborate closely with internal stakeholders, external laboratories, and toxicology experts to support the safety and compliance of innovative medical devices throughout their lifecycle.
What you’ll do
* Develop and maintain robust, documented systems for Biological Safety Evaluations of medical devices
* Author Biological Evaluation Plans and Reports in line with ISO 10993 and FDA requirements
* Maintain accurate and compliant records supporting biological safety assessments
* Review engineering and manufacturing changes, assessing their impact on device biosafety
* Liaise with external test laboratories and consultant toxicologists to plan and execute testing programmes
* Provide expert input into Vigilance activities, advising on biological safety risks
* Support New Product Introduction (NPI) by delivering biosafety data to meet project timelines
* Present and discuss biological safety findings with regulatory bodies where required
About You
* Degree in a life sciences discipline (Biology, Bioengineering, or Chemistry preferred)
* Strong understanding of biological safety evaluation requirements for medical devices
* Excellent communication skills, with the ability to collaborate effectively across teams and with external partners
* Proficiency in Microsoft Word and Excel
* Knowledge of toxicology or pharmacology
* Familiarity with Quality Management Systems, including ISO 13485 and FDA QSR
* Experience working with medical devices across classifications (Class I–III)
Why Join Us?
* Opportunity to work on innovative, life-changing medical technologies
* Collaborative and supportive team environment
* Career development within a growing global organisation
* A competitive salary and a discretionary annual bonus
* Excellent pension – starts at 6%, going up to 9.7% after 18 months.
* Life assurance – Six times your basic salary
* Private medical insurance with BUPA for you and your family
* Free annual eye tests and flu vaccinations
* Employee referral program where you can earn up to £1,000 for each successful hire you recommend
IND007
Corin provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
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