Quality and Regulatory Affairs Manager
- Experience Level
Quality & Regulatory Affairs Manager
My Client, a global company with offices in Dublin now have a new role available for a Quality & Regulatory Affairs Manager.
As Quality & Regulatory Affairs Manager you will be responsible for leading the regulatory affairs and quality assurance functions within the Company. Their products are currently available in 5 countries worldwide and this will increase.
- Provide Quality & Regulatory strategic direction, training and support.
- Responsible for ensuring business activities are conducted in compliance with the regulations and standards applicable to our business and product range
- Lead 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 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.
FULL JOB SPEC ON REQUEST
To be considered for this role we are looking for candidates that meet the following criteria:
- 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.
- Excellent communication and inter-personal skills.
- Strong planning and organizational ability.
- The ability to carry out work in a fast-paced organisation.
- Ability to influence peers and colleagues and ensure that they understand with great clarity what is expected from them from the quality and regulatory department. Ensuring colleagues understand the why are supportive of the needs of the Q&R department.
For full job spec and confidential discussion contact Tina at +353 1 2784671 or email your CV to email@example.com. Thornshaw is a division of the CPL group of companies. www.thornshaw.com