Regulatory Affairs & Quality Assurance Consultant

Are you an experienced regulatory affairs and/or quality assurance professional looking for a new challenge? If so, we have just the opportunity for you!

LFH is a top medical device consultancy company that is seeking a permanent Regulatory Affairs & Quality Assurance Consultant. We are open to full time as well as part time applicants between 3 to 5 days.

What benefits will you get?

Competitive Salary and compensation package: We understand the value of your skills and expertise. We offer?

• A salary of up to £55k pro rata depending on experience
• Company based bonus scheme
• Life Insurance

Professional growth and development: You’ll have the opportunity to work on a diverse range of projects, from writing and editing regulatory documents to providing oversight for outsourced deliverables to our clients. You will be able to enhance your skills and broaden your knowledge in the field of medical device regulation. Not only this, as the business is rapidly growing year on year, there is no limitations on where you can go in the company with many exciting opportunities ahead !

Stimulating work environment: Join a team at the forefront of medical device & IVD regulation, where every day brings new challenges and opportunities to make a difference and learn new things. Collaborate with cross-functional teams and contribute to the development of crucial regulatory documents that impact the advancement of medical technology.

About LFH Regulatory

We work with varying companies, that have diverse ranges of technologies which offers a stimulating work environment, and ample opportunities for professional growth and development. If you like working from home, know that this job is fully remote but with occasional travel.

Our services include device development and CE/UKCA marking certification, global regulatory strategies, US FDA, quality management system creation and ongoing support to ISO 13485, internal/supplier audits, remediating audit findings, technical documentation, risk management activities to ISO 14971, clinical requirements, recalls and adverse event management, product registration, and UK Responsible Person services.

The Role Description

Client facing responsibilities, including, but not limited to:

The Regulatory Affairs & Quality Assurance Consultant will be responsible for managing client projects that includes:

Attend client meetings both remote and onsite as needed,

Implement full and partial quality management systems, that align with UK, EU, and US requirements/ISO 13485/21 CFR, by creating/writing procedures, controlled forms, and work instructions,

Maintain client quality management systems and provide QMS support to clients,

Conduct gap assessments and audit quality management systems,

Provide support to clients pre, during and post audit, including audit preparation, attending audits and assisting with non-conformities,

Create, maintain and conduct gap assessments on technical file documentation for clients, including but not limited to:

• Essential Requirements Checklist (ERCs) and General Safety and Performance Requirements (GSPRs),
• Clinical Evaluation,
• Biological Evaluation,
• Usability Engineering,
• Instructions for use and labels,
• Applied standards,

Register devices with regulatory authorities,

Review and prepare UK responsible person documentation,

Liaise with notified/approved bodies and competent authorities.

LFH responsibilities, including, but not limited to:

Attend and participate in team meetings both remote and face to face,

Create blog content for LinkedIn/Website and any other form of social media where required,

Create, update, and maintain internal LFH Regulatory business processes and document employee training records,

Represent the business at exhibitions, conferences, and networking events as required.

What are the requirements?

• Must be based in the UK.
• Willingness to learn and grow: We are looking for a motivated candidate who is eager to learn and grow as part of a team. A willingness to continuously develop your skills and contribute to the team’s success is essential
• Problem-solving skills
• Your ability to anticipate issues, drive project consensus, and find solutions will be crucial in this role
• Knowledge of medical device regulations and standards, including EU MDR, IVDR, and ISO 13485
• Experience with device development, quality management systems, audits, technical documentation, risk management, and clinical requirements
• Understanding of recalls and adverse event management, product registration, and UK Responsible Person requirements
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team
• Attention to detail and strong analytical skills
• Bachelor's degree or higher in a related field.
• US FDA experience
• Experience with Software as a Medical Device (SaMD)
• Implementation of full and partial quality management systems by creating/writing procedures, controlled forms, and work instructions
• Relevant certifications or qualifications in regulatory affairs

Apply now and become a part of this exciting journey!

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