Permanent

Regulatory Affairs Team Leader

LocationOulton, West Yorkshire, Yorkshire, England
Salary
SectorCompliance
Job RefBH-96295
ContactWill Godfrey
Published4 months ago

Jetzt bewerben

Will Godfrey

Billing Manager

Apply Now

Save job

Übersicht

Austin Vita are delighted to be offering a fully remote, permanent, job opportunity for an experienced Medical Device Regulatory Affairs professional to join a well established Regulatory Group as a Team Leader working on Class III Devices for a global manufacturer.

Responsibiliites:

Preparation and review of regulatory documentation and submissions for product approval.
Development of regulatory plans/strategies for new products and changes to existing products.
Participation in Design Control, Risk Management and Post Market Surveillance activities.
Production and review of design dossiers, technical files and change assessments.
Review and preparation of regulatory paperwork in accordance with International standards and new regulations.
Review of product packaging, labelling, IFUs and marketing literature for compliance with specific country regulations.
Facilitate compliance with Vigilance System.
Provide regulatory input to functional groups as required.
Participate in review of RA procedures.
Review and approval of validation, protocols and reports.
Mentorship of RA Associates

For immediate consideration please forward your most up to date CV

Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.

Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.

Check us out on our website and LinkedIn for more roles.

We respect your personal data and would never offer it to third parties! For more information on how we handle your data, feel free to check out the Austin Fraser Privacy Notice or contact privacy@austinfraser.com Austin Fraser International Ltd is registered in England: 14971372 Austin Fraser International Ltd, 33 Soho Square, London, W1D 3QU

Contract

Diesen Job teilen

Neue Stellen

Senior Quality Engineer

This is a fantasy opportunity for a Senior Quality Engineer to join a Global Medical Device company based in North Yorkshire. You will be responsible for supporting the compliance team to ensure all required certification is maintained.

Main Tasks/Responsibilities:

Complete internal audits in compliance with ISO 13485, 21 CFR, MDD/MDR and UKCA regulations.

Responsible for the logging, investigating, and documenting of non-conformities, ensuring appropriate action is taken to correct the issue and prevent recurrence, these must be completed within appropriate timescales including:

Corrective and Preventative Action Reports (CAPA)

Non-Conformity Reports (NC)

Regulatory reporting

Prepare trending analysis data whilst escalating any trends to a CAPA. Assist with preparation for the Quality Review Meeting.

Assist in the implementation of compliant processes and QMS documentation across multiple sites.

Responsible for the review and implementation of third-party agreements.

Undertake any other duties as may be requested.

Knowledge and Qualifications:

Essential:

Experience of working in a Quality environment, within the Medical Device Industry.

Experience of auditing to ISO 13485, preferably at Lead Auditor level.

Experience of generating and completing CAPA/Complaints and Root Cause Analysis.

Desirable:

Experience/knowledge of auditing the MDR, 21 CFR and UKCA regulations.

Experience/knowledge of reporting incidents to competent authorities.

Experience in writing processes compliant with standards.

Experience of ISO 14001.

Skills/Competencies:

Excellent interpersonal skills, including the ability to work as part of a team and to work with people from across the whole company.

Good organisation and leadership skills and attention to detail.

Good written and verbal communication skills.

A can-do attitude with the ability to take initiative and work to deadlines across multiple simultaneous tasks and projects

Problem Solver

Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.

Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.

Check us out on our website and LinkedIn for more roles.

We respect your personal data and would never offer it to third parties! For more information on how we handle your data, feel free to check out the Austin Fraser Privacy Notice or contact privacy@austinfraser.com Austin Fraser International Ltd is registered in England: 14971372 Austin Fraser International Ltd, 33 Soho Square, London, W1D 3QU

Senior Quality Engineer

This is a fantastic opportunity for an experienced Senior Quality Engineer to join a Medical Device Manufacturer based in the beautiful county of Devon.

You will work closely with the Quality Manger in the development, implementation, and maintenance of company quality procedures, standards, and specifications. You will play a critical role in ensuring that these controls are robust, fully implemented, and upheld across the business. This position will also require you to lead and manage the internal audit process, acting as the primary point of contact for site-related audits.

In this role, you will collaborate with the Quality Team to foster a culture that emphasises the importance of quality and teamwork, driving collaboration throughout the buisness. By providing guidance and leadership across departments, you will work closely with Leaders on site to ensure that all products meet the highest standards of quality and reliability. Additionally, you will be responsible for reviewing and approving technical and engineering documentation, ensuring that processes are correctly followed and adhered to.

Your ability to communicate effectively with the Operations team is key, as you will collaborate on development activities and resolve any quality concerns. You will also take charge of managing customer complaints, ensuring that all procedures are followed and that documentation is accurately and promptly completed. Furthermore, you will lead problem-solving initiatives, working across departments to identify and implement improvements.

Qualifications:

To be successful in this role, you will need at least 5 years of experience in quality systems /quality engineering, with a proven background in a manufacturing environment. You must have a strong understanding of quality methodologies and techniques, as well as in-depth knowledge of ISO 13485.

Benefits

The business offers benefits such as; hybrid working (up to 2 days a week working from home), 25 days annual leave (plus bank holidays and increasing over length of service), ongoing training and development, health care plans, pension scheme, and more.

Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.

Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.

Check us out on our website and LinkedIn for more roles.

We respect your personal data and would never offer it to third parties! For more information on how we handle your data, feel free to check out the Austin Fraser Privacy Notice or contact privacy@austinfraser.com Austin Fraser International Ltd is registered in England: 14971372 Austin Fraser International Ltd, 33 Soho Square, London, W1D 3QU

Regulatory Affairs Specialist - 12 month FTC

£35000 - £50000 per annum

This is a fantastic opportunity for a Regulatory Affairs Specialist to join a global medical device manufacturer based in the South East. The position is being offered on a 12 month Fixed Term Contract basis, and offers hybrid working (at least 2 days per week on site).

Benefits:

Flexible working hours
Hybrid working
Pension Scheme
Private Medical Cover

The Role
You will be involved in supporting change management activities, collaborating with different departments across Quality, R&D, and Manufacturing to help manage sustaining changes across the medical device portfolio, incorporating the review/approval of change requests.

You will represent Regulatory Affairs in weekly change boards and ensure the appropriate regulatory action is taken during implementation of change. The role will also work with counterparts globally, assessing potential impact of planned changes and communicating implemented changes so experience working in a global matrix environment would be ideal.

Other responsibilities include:

Generating/maintaining technical documentation for compliance to applicable regulations
Supporting regulatory compliance projects (EU MDR and NPD/sustaining projects for example)
Driving process updates and contributing to process improvement

Experience required:

Medical Device Regulatory Affairs
University degree in a scientific subject
Excellent communication and organisational skills
Ability to work with cross-functional teams and diverse cultures