Company Information

QA & RA Specialist

Zenopa is partnering with a growing company who are commercializing cold plasma technology and driving into new markets.
They are looking for a QA and Regulatory Affairs Specialist to join their dynamic Medical Devices team. The ideal candidate will join a team who are looking to launch innovative technology with both Medical and Engineering applications.

The candidate will play a fundamental role in maintaining continued regulatory compliance with standards and medical device regulations. Training and education will be provided as required to enable the candidate to develop their potential and build on their skillset.

Key accountabilities:
- QMS management (Quality Manual, policy, Quality objectives, QMS planning, QMS meeting, staff training, Change Plan)
Management, maintenance, and compliance (ISO13485/MDR/UKCA) with Standard Operating Procedures (SOPs), internal policies related to Quality Management System and their training to the relevant individuals.
- Responsible for management and planning of the internal audit programme and conducting internal audits. Supporting external NB audits.
- Post-Market Surveillance activities -Implementation of PMCF plans ullet PMS data collection, analysis, reporting ullet Clinical Evaluation Report inputs, review and update
- MDR and UKCA planning and implementation
- Review of Technical Files, Risk Management and GSPR

Person Specification:
- Drive to succeed - The drive and ambition to put energy into achieving results and take action to exceed goals and expectations.
- Flexibility and Resilience - the ambition to achieve results in demanding business environments. Be resilient, adapt and respond positively to a variety of situations and people to meet changing priorities.
- Quality objectives - The desire to meet the needs and expectations of regulatory compliance, product quality and the Adtec Brand.
- Initiative - The drive to identify or anticipate changes, including an active and creative approach to addressing those opportunities or challenges.
- Attention to Detail - The desire to achieve accuracy, conscientious and have a passion for excellence in all tasks.
- Communication, impact & influence - The ability to convince, persuade, influence or impress others (internally and externally)
towards a point of view, including working collaboratively with others to gain agreement to a course of action, idea or future vision.

Please reach out to matthew@zenopa.com or graham@zenopa.com to discuss further.