Biocomposites
Risk Management Specialist
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Job Description
Company Overview
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.
Job Summary
The Risk Management Specialist is responsible for support of risk management activities for both new and commercially released medical devices throughout the product lifecycle, ensuring compliance with ISO 14971, applicable global medical device regulations, and company quality management system requirements.
Working cross-functionally, the role identifies, assesses, mitigates, and monitors product risks during development and through post-market surveillance activities to ensure patient safety and regulatory compliance.
Reports to
R&D Project Manager
Location & Working Pattern
- Working location: Keele Office.
- Working hours: Monday - Friday 0800 - 1600 or 0900 - 1700
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Duties & Responsibilities
- Assist in the creation and maintenance of Risk Management files for medical devices, including:
- Failure mode effects analysis scoring system
- Risk management plans
- Preliminary hazard analysis reports
- Risk hazard analysis reports
- Register of risks (DFMEA)
- Risk-benefit analysis
- Risk-traceability analysis
- Anomalies review reports
- Risk management reports
- Identify risks using applicable risk assessment tools, and best practice tools and techniques.
- Periodically review risks and risk control measures to update, eliminate, or add risks as appropriate, including the evaluation of post-market surveillance data, complaints and CAPAs.
- Participate in risk reviews for proposed design changes.
- Create risk control requirements as inputs to product design.
- Ensure that the effective operation of risk management can be evidenced and provide confidence to internal and external stakeholders.
- Ensuring a culture of risk-based decision-making is maintained within the organisation.
- Other duties in support of the company’s quality policy and objectives.
- Support submissions to regulatory authorities by providing risk management documentation and risk-based justifications as required.
Essential Requirements
- Level 6 within a science regulated industry or relevant experience.
- Minimum 3 years of risk management experience in Pharmaceutica/Medical Devices.
- Knowledge of Quality Management Systems (ISO 13485) and risk management principles (ISO 14971).
- Excellent communication skills.
- People management skills.
- Ability to take initiative within controlled working environment.
- Ability to meet deadlines.
- Attention to detail.
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Desirable Requirements
- Level 5 in Leadership Management.
- Certification in Risk Management.
- Experience with supporting risk documentation for submissions to regulatory authorities.
- Ability to work in a diverse, dynamic and fast-paced environment.
- Excellent team player, with strong interpersonal and communication skills.
- Full, clean driving licence.
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
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