Quality & Regulatory Affairs Manager
- Experience Level
Role: Quality & Regulatory Affairs Manager
Location: fully home-based (20% travel to manufacturing sites & main offices on an Adhoc basis)
Salary: Highly competitive + benefits
employment: full time, permanent
CPL Life Sciences are collaborating with a family-run eye-care business that supports Clinicians and Patients in managing a variety of Ocular Surface Diseases. Our client is looking for an experienced Quality & Regulatory Affairs Manager to join their team in either the UK or Dublin. This is a stand-alone position with the view to growing/develop a team within 12 months (depending on growth and workload, this may happen sooner). You will be responsible for managing the Quality and Regulatory Affairs function within the business, ensuring theyre fully compliant and focused on continuous improvement ensuring product quality and customer satisfaction.
Other duties will include:
Offer Quality & Regulatory strategic direction, training, and support to our client
Responsible for ensuring our clients business activities are conducted in compliance with the regulations and standards applicable to our business and product range
Lead our clients Quality Management Systems including Documentation, Complaints Management, CAPA, and Management Review.
Responsible for the overall development, implementation, and maintenance of the organizations Quality Management System (QMS) for all of its product classifications
Ensure Quality System processes are lean, compliant, user-friendly, and are well understood throughout the organization.
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.
Maintain an ISO13485 Quality System incorporating the companys existing medicinal QMS.
Act as our Responsible Person for Medicinal Products under the companys Wholesale Distribution Licence (WDA).
Work to act as RPI for medicinal products in the UK and Northern Ireland.
Adapt existing procedures and documents that best meet the requirements of QS and the workflow within the Company.
Carry out training and communication activities with staff to ensure adequate understanding of Quality Systems and Regulatory requirements.
Interact with Regulatory Bodies to provide information on requirements for Certifications and approvals.
Provide Quality and Regulatory inputs into Clinical studies.
Provide technical leadership and vision through the interpretation of new and emerging international regulatory trends pertinent to local business needs and develop and implement strategies and projects to optimize regulatory performance
Responsible for final sign-off on all product labels, package inserts for our clients products.
Work through the Brexit requirements for our business across the different classes of products.
Right to work in the UK or EU
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 environments 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.
Ability to work independently, prioritizes multiple projects, addresses multiple issues, and handles multiple deadlines, in a hands-on environment
Excellent communication and interpersonal skills.
The ability to carry out work in a fast-paced organization.
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.
If you would like to apply for this position, please contact Amani via amani.yousef@CPL.com. If you are not currently looking but know someone who would be good for this role then get in touch. We offer a referral scheme at Regulatory Professionals where in which a successful recommendation will earn you 250 worth of vouchers *terms and conditions apply*
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