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Role - Quality & Regulatory Officer - Medical Device
Location - Banbury, Oxfordshire 2/3 days per week
Salary will be dependent on experience and potentially negotiable for the right person - circa £40k-45k plus bonus and package
Company -
The QA/RA manager is a hands-on role with direct responsibility for developing, implementing and enforcing quality management procedures and systems. This role is initially a stand alone in the QARA function (apart from x1 part time assistant). You will be expected to grow in the role and it is likely to become a leadership position.
Key functions.
Maintain compliance and timely registration for licensing and products associated with the business. Identify compliance issues that require follow-up and conduct internal investigation of compliance issues with the aim of continuously looking for process improvements and ruling out non-compliance issues. Fully responsible for application, monitoring and process management of multiple ISO certificates and licenses vital to the business. Liaise with external suppliers, internal staff and stakeholders and all regulatory bodies. In addition to managing the QARA function for in-house manufacturer products the appointed person will work closely with strategic partners / suppliers to ensure adherence to al standard. In this role the QARA Officer will also be
registered as the RESPONSIBLE PERSON.
The perfect candidate will be experienced in medical device QARA and will have ISO experience.
They do not need experience and a Responsible Person, but this would be an advantage - as will MDA and CE knowledge.
Skills/qualifications:
Knowledge, Skills, and Abilities
- Quality/Regulatory qualification
- Working knowledge of ISO certification
- Effective communication and report writing skills.
- Good negotiation skills with customer-oriented attitude.
- Excellent analytical abilities to grasp the key points from complicated details.
- Good leadership capabilities to lead projects to successful completion.
- Basic knowledge of applicable software to infer statistical data.
- Familiarity with the tools, concepts and methodologies of quality management
To apply for this - or any of our exciting opportunities in the medical devices sales market - Apply Online
