MDR Quality Associate
Hobson Prior are recruiting for an MDR Quality Associate for an exciting opportunity to join a leading organisation who develops and manufactures pharmaceutical products. This position will ensure MDR Implementation for the successful re-certification of medical device product portfolio within the boundaries of quality, time and budget.
- Responsible to support the organisation's transition planning of medical device product portfolio from MDD to MDR.
- Complete comprehensive review of MDR gap assessment for products.
- Support remediation of MDR compliance gaps identified during assessment
- Provide Guidance to multifunctional teams to ensure MDR certification requirements are met for medical device product portfolio.
- Provide product quality support to implement revised product labelling, product verification and validation, risk management, clinical evaluation, post market surveillance and support sustaining product activities to achieve MDR compliance.
- Represent as the QA Approver for product verification and validation and MDR product Change Controls.
- Review product documentation for accuracy and compliance to MDR.
- Provide Guidance on maintenance of product Design History Files and Risk Management Files according to Quality System.
- Must possess excellent interpersonal, verbal, and written communication skills at all levels internally and externally.
- Extremely organized, and be customer focused with strong interpersonal skills.
- Capability to work with minimal supervision.
- R&D minded.
- University degree in Pharmacy, Engineering, chemistry, biochemistry.
- Number of years of experience: 2 to 3 years in Pharmaceutical/medical devices industry per EU and/ or FDA requirements (GLP/GMP/ISO13485 regulation).
- Knowledge of MDR regulation is a must.
- Experience in Quality Initiatives (processes, systems, improvements) is a must.
- Field of expertise: Analytical method development/validation, laboratory activities or stability studies is an asset.
- Knowledge required: Word, Excel, Outlook.
- Compliance knowledge in the areas of product development, MDR, , change control, CAPA.
- English is a must (French/Dutch is nice to have).
- Microsoft office application.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
£55000.00 - £65000.00 per annum
Hobson Prior are currently working with a specialty biopharma organisation who are focused on the advancing and manufacturing biosimilar medicines.