PMS (Post-Market Surveillance)/Risk Specialist

Alivedx; City of Edinburgh; On-site; GBP 30,000 - 60,000; Full time

Job summary

An innovative firm is seeking a PMS/Risk Specialist to ensure compliance with regulations and manage risk in product development. This role involves conducting Post Market Surveillance activities, providing guidance to team members, and maintaining knowledge of regulatory requirements. You'll be part of a dynamic environment that fosters innovation and customer-centric solutions. If you have a passion for improving patient care and possess a strong background in risk management, this is the perfect opportunity for you to make a significant impact in the biotechnology sector.

Benefits

Flexible working environment

Pension

Private medical cover

Life assurance

Qualifications

• Experience in risk management and Post Market Surveillance activities.
• Ability to prepare coherent regulatory reports.

Responsibilities

• Ensure compliance with Product Risk Management Processes and regulations.
• Conduct duties in compliance with GMP and GDP.

Skills

Risk Management

Post Market Surveillance (PMS)

Regulatory Reporting

Attention to Detail

Communication Skills

Collaboration Skills

Education

Science Degree or Equivalent

Job description

PMS (Post-Market Surveillance)/Risk Specialist

Company: AliveDx

At AliveDx, we empower diagnostic insights, transform patient care, and innovate for life. With over 30 years in in-vitro diagnostics, we prioritize patient health by creating innovative solutions designed for faster diagnostic results.

Location: Near Edinburgh (EH26 0BF)

Role Overview: The PMS/Risk Specialist will ensure compliance with all relevant regulations through the completion of Product Risk and Post Market Surveillance (PMS) activities. This role involves managing risk throughout the Design Control Process for new projects and through Core QMS processes for products on the market.

YOUR MISSION

Your main responsibilities will include:

• Ensure Product Risk Management Processes are compliant with relevant Risk Management Regulations.
• Conduct all duties in compliance with Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP).
• Provide support, guidance, and training to team members in Risk Management and PMS.
• Maintain knowledge of new or updated regulatory requirements and industry standards.
• Participate in regulatory inspections or certification audits.
• Promote risk culture within the organization, including Risk Based Approach and Continuous Improvement.
• Act as a Risk Management Team Representative during Third Party Audits.
• Create and update PMS documentation in line with IVDR requirements.
• Carry out PMS activities for compliance with required schedules.
• Lead and support all Product Risk Management activities.

YOUR COMPETENCIES

• Science Degree or Equivalent qualification.
• Experience in risk management.
• Experience in Post Market Surveillance activities (PMS).
• Ability to prepare coherent regulatory reports.
• Specialist knowledge of regulations applicable to medical devices and in vitro diagnostic medical devices.
• Great attention to detail, communication, and collaboration skills.

WHAT WE OFFER

• A dynamic and growing environment.
• An opportunity to cultivate innovation and customer centricity.
• A flexible working environment and a range of benefits including pension, private medical cover, life assurance, and more.

Interested? We look forward to receiving your application.

AliveDx is an equal opportunity employer and welcomes applications from all qualified individuals.

Seniority Level

Associate

Employment Type

Full-time

Job Function

Manufacturing and Science

Industries

Biotechnology Research and Medical Equipment Manufacturing