Quality & Regulatory Manager
- Experience Level
My client, medical devices and pharmaceutical company based in South Dublin is recruiting for a Quality and Regulatory Manager.
Quality & Regulatory Affairs Manager is responsible for leading the regulatory affairs and quality assurance functions within the company. The company’s products are currently available in 5 countries worldwide and this will increase. Our Quality and Regulatory Affairs Manager will manage this department effectively to keep the company compliant and focused on continuous improvement ensuring product quality and customer satisfaction.
- Provide Quality & Regulatory strategic direction, training and support to the company.
- Responsible for ensuring the company’s business activities are conducted in compliance with the regulations and standards applicable to our business and product range
- Lead company’s Quality Management Systems including Documentation, Complaints Management, CAPA and Management Review.
- Responsible for the overall development, implementation, and maintenance of the organisation’s Quality Management System (QMS) for all of its product classifications; medicinal, medical device, cosmetic, food supplement products.
- Ensure Quality System processes are lean, compliant, user-friendly and are well understood throughout the organisation.
- In collaboration with the Management Team, drive continuous improvement and best practices in company’s Quality systems.
- Externally this position interacts with regulatory agencies, industry organizations, consultants, suppliers, legal counsel and health care professionals.
- Responsible for ensuring adherence to all external regulatory requirements – MDR 2017/745 and 21 CFR 820.
- Manage internal and external audits.
- Maintain and follow up CAPAs.
- Responsible for the implementation of Quality Agreements with partners.
- Enhance a compliance culture throughout the organisation.
- Maintain an ISO13485 Quality System incorporating the company’s existing medicinal QMS.
- Act as our Responsible Person for Medicinal Products under the company’s Wholesale Distribution Licence (WDA).
- Work to act our as RPI for medicinal products in the UK and Northern Ireland.
- Interact with Regulatory Bodies to provide information on requirements for Certifications and approvals.
- Provide Quality and Regulatory inputs into Clinical studies.
- Third level qualification in Quality & Regulatory Affairs. An additional qualification in Life Sciences is desirable.
Specific Knowledge, Skills and Experience
- At least 8 years post-graduation experience in Quality & Regulatory environment with at least 5 years at a similar level.
- Experience in management of Quality Systems in a Medical Device/Pharmaceutical Industry.
- Excellent knowledge of ISO 13485, CE and FDA requirements, with experience supporting regulatory submissions
- Experience dealing with Notified Bodies relating to Medical Devices
- Experience In technical file writing.
- Proven track record of regulatory submissions of technical files.
- Experience in CAPA system management.
- Six Sigma training desirable.
- Regulatory experience and knowledge in the following areas; medicinal, medical, cosmetic and food supplement.
- GMP Experience
- Ability to work independently, prioritizes multiple projects, addresses multiple issues, and handles multiple deadlines, in a hands-on environment
- Good supervisory, technical writing and investigation skills are required.
For a full Job Spec and to apply for this role please call Zoe on +353 1 2784671 or e-mail firstname.lastname@example.org
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671
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