Job Description
Biocomposites, Ltd. is an international medical devices company that engineers, manufactures and markets world-leading products for infection management in bone and soft tissue. Based in Keele, Staffordshire, UK, it has global operations across Europe, USA, Canada, Argentina, China, and India, helping more than 1 million patients worldwide annually.
Our team focuses on developing innovative calcium compounds, with all research, manufacturing, and distribution centralized at our headquarters in Keele. In 2022, we received two Queen’s Awards for Enterprise in Innovation and International Trade, recognizing STIMULAN's impact in infection cases and our growth in overseas sales by over 200% in six years. Our products are used in over 120,000 procedures yearly and sold in more than 40 countries.
Job Summary
Our graduate scheme offers technical, functional, and behavioral skills to kick-start your career and expand your professional network. This development role involves supporting regulatory activities while gaining a solid foundation in regulatory affairs.
We currently have 2 vacancies.
Responsibilities
* Prepare and submit documents to maintain the company’s site and product registrations according to country-specific requirements.
* Assess and understand the impact of design changes on regulatory compliance and product registration maintenance.
* Use information systems to track registration statuses and renewal deadlines.
* Maintain awareness and support colleagues regarding the regulatory status of products in relevant countries.
* Assist in creating technical documentation for product registrations.
* Support activities within the regulatory and compliance teams.
Essential Requirements
* Bachelor’s Degree in a life science or equivalent.
* Medical Devices training or qualification.
* Strong organizational skills and ability to meet tight deadlines.
* Excellent team skills.
* Enthusiastic, eager to learn, and motivated to develop a career in Regulatory/Medical Devices.
* Proficient in Microsoft Office.
* Excellent communication skills for liaising within the company and with external customers.
Desirable Requirements
* Knowledge of ISO 13485.
* Knowledge of Medical Devices.
* Understanding of regional regulatory requirements.
* Knowledge of complaints handling, post-market surveillance, and clinical report writing.
Location
Keele Head Office / Hybrid work, Monday - Friday, 9:00 - 17:00 or 8:00 - 16:00, 35 hours/week.
What We Offer
* Competitive salary and benefits.
* Opportunities for growth and development.
* Inclusive and engaged team culture promoting diverse perspectives.
Who We Look For
* Passionate individuals committed to our mission.
* Open-minded team players eager to evolve and innovate.
* Collaborative people dedicated to transforming outcomes and changing lives.
Benefits
* Company events
* Company pension
* Employee discounts
* Travel subsidies
* On-site parking
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