Risk Management Specialist

Biocomposites Limited; Keele; On-site; GBP 40,000 - 75,000; Full time

Job summary

An established industry player is seeking a Risk Management Specialist to join their innovative team. In this pivotal role, you'll create and maintain comprehensive Risk Management Files, ensuring the safety and effectiveness of medical devices throughout their lifecycle. With a focus on risk assessment and management, you'll work closely with cross-functional teams to promote a culture of proactive risk management. This dynamic position offers opportunities for professional growth within a supportive and inclusive environment, making a significant impact on patient safety and product quality. If you have a passion for risk management and thrive in a fast-paced setting, this is the perfect opportunity for you.

Benefits

Company events

Pension

Employee discounts

Travel subsidies

Free parking

Qualifications

• 5+ years of risk management experience in Pharmaceuticals/Medical Devices.
• Knowledge of ISO14971 QMS and FMEA scoring systems.

Responsibilities

• Create and maintain Risk Management files for all products.
• Identify risks using appropriate assessment tools and techniques.
• Promote a risk-based decision-making culture.

Skills

Risk Management

FMEA

ISO14971 QMS

Communication Skills

Leadership Management

Education

Level 6 qualification in a science regulated industry

Level 5 in Leadership Management

Job description

Join to apply for the Risk Management Specialist role at Biocomposites.

Biocomposites, Ltd. is an international medical devices company specializing in infection management products for bone and soft tissue. Based in Keele, Staffordshire, UK, with global operations across Europe, USA, Canada, Argentina, China, and India, helping over 1 million patients annually.

The company focuses on developing innovative calcium compounds at its headquarters in Keele, England. Recognized with two Queen’s Awards for Enterprise in Innovation and International Trade in 2022, its products are used in over 120,000 procedures yearly across more than 40 countries.

Background

Biocomposites is experiencing rapid growth, aiming to expand market coverage in new specialties and geographies.

Role Overview

The Risk Management Specialist will create and maintain Risk Management Files for all products throughout their lifecycle, including FMEA scoring systems, risk management plans, and various analysis reports.

Responsibilities

1. Assist in creating and maintaining Risk Management files, including FMEA, risk management plans, hazard analysis, and risk reports.
2. Identify risks using appropriate assessment tools and techniques.
3. Review and update risks and treatment strategies periodically.
4. Participate in risk reviews for design changes.
5. Create risk control requirements for product design.
6. Ensure effective risk management operation and stakeholder confidence.
7. Promote a risk-based decision-making culture.
8. Support the company’s quality policy and objectives.

Required Experience

1. Level 6 qualification in a science regulated industry or relevant experience.
2. Minimum 5 years risk management experience in Pharmaceuticals/Medical Devices.
3. Knowledge of ISO14971 QMS.
4. Excellent communication and people management skills.
5. Ability to take initiative, meet deadlines, and pay attention to detail.
6. Level 5 in Leadership Management and membership of a chartered institute.
7. Ability to work in a diverse, dynamic, fast-paced environment and be a strong team player.

What We Offer

• Competitive salary and benefits.
• Opportunities for growth and talent development.
• Inclusive, engaged team culture.

Benefits

• Company events, pension, employee discounts, travel subsidies, free parking.

Additional Information

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Finance and Sales
• Industry: Medical Equipment Manufacturing