Job Description

Biocomposites is an international medical devices company that engineers, manufactures, and markets world leading products for use in infection management in bone and soft tissue. Based in Keele, UK, it has global operations across Europe, USA, Argentina, Canada, China, and India. Biocomposites is a world leader in the development of innovative calcium compounds and bone cements for surgical use. Its products regenerate bone and target infection risks across a variety of specialties, including musculoskeletal infection, orthopaedics, trauma, spine, foot and ankle, podiatry, and sports injuries. Biocomposites products are now used in over one million procedures per annum and sold in more than 100 countries around the world.

The Technical Associate role will provide scientific support for the R&D and regulatory team supporting new product development as well as supporting lifecycle management of existing products and expansion of regulatory submissions into new territories.

The post holder will ensure pre-clinical testing is conducted according to regulatory standards, ensuring the data is provided in a suitable format to support regulatory submissions. The postholder will also be experienced in scientific writing, have good communication skills, and experience in project management to ensure the projects are completed on time.

Reports to

Pre-Clinical Research Specialist

Location & Working pattern

Keele office, standard working hours are Mon-Fri 8.00-4.00, 35hpw

Duties & Responsibilities

• Support the Preclinical submissions and interactions with regulatory agencies such as the FDA, MHRA, EMA, etc.
• Ensure preclinical studies comply with SOPs, regulatory guidelines, and ICH requirements.
• Have the ability to relay complex information to both internal stakeholders and external collaborators.
• Contribute to risk assessments per ISO 14971 and biological evaluations per ISO 10993-1
• For Biocomposites products, conduct literature reviews on the background material of the device and similar devices
• To support the execution of the Biological evaluation plan (BEP) and Biological Evaluation reports (BER) addressing the biocompatibility endpoints identified in ISO 10933-1 for Biocomposites products.
• To manage external CRO and contract laboratories for required testing
• To offer scientific support to other teams within the company as required (sales, marketing, regulatory)
• Keep up to date on literature relating to Biocomposites products and competitor products.

Essential requirements

• Level 6 Diploma (level 6 NVQ ordinary degree, degree with honours, degree apprenticeship) in a scientific discipline.

• Experience with contract research organisations.

• Understanding of regulatory requirements for new products including biocompatibility and other pre-clinical testing.

• Knowledge of ISO and FDA regulations for medical devices.

• Excellent communications skills.

• Sound scientific writing for different audiences.

Desirable requirements

• Level 7 Diploma (level 7 NVQ, master's degree, postgraduate certificate) in a scientific discipline.
• Ability to manage multiple projects and work to deadlines.
• Experience combination products.

• Project management experience.

• Able to work as part of a team.

• Car driver.

What do we offer?

Competitive salary and benefits! With us, you will receive a competitive salary package and benefits.

We grow talent. At Biocomposites we create opportunities to thrive and grow.

One Biocomposites – team spirit & engagement. Our culture is important and we strive to create engaged and inclusive global teams that encourage colleagues to share their diverse perspectives and opinions.

Who do we look for?

People who are passionate about what we do.

People who are open minded to evolving the way we work.

People who can work together to transform outcomes and change lives.

Benefits:

• Company events
• Company pension
• Employee discount
• Free or subsidised travel
• Free parking
• On-site parking