Regulatory Consultant - Warwickshire, United Kingdom - TEC PARTNERS LIMITED

TEC PARTNERS LIMITED

Verified Company

Warwickshire, United Kingdom

1 week ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

TEC Partners are pleased to have partnered with a pioneering consultancy who cover a broad range of medical devices on behalf of medical device manufacturers who are in the early stages of their development, who require direct industry knowledge to streamlineand get their products ready for market release within the European and US markets.

Regulatory Consultant:

As Regulatory Consultant, you will provide expertise across European and American markets for medical device companies while managing prospective clients and UK/CE Technical Files in order to ensure compliance to current regulations with in-vitro medicaldevices.

The role will entail client meetings to conduct Regulatory, Quality meetings, audits and any other relevant regulatory requirements.

Regulatory Consultant Responsibilities:

Provide support to other members of the team and Managing Director, when requested
Oversee regular communication with clients as to provide accurate and concise updates on regulatory changes that could affect their business
Ensure compliance in line with ISO 13485 accreditation
Represent the company in a professional and courteous manner
Any other tasks required by the company director

Regulatory Consultant Requirements:

Degree or equivalent certification in science related, medical or engineering discipline
Well versed and knowledgeable of the medical device industry with at least 5 years' experience
Proven ability to ass all necessary and specific medical device regulatory obligations and to be able to advise staff and clients accordingly
Well rounded experience verifying technical, design and manufacturing information
Quality Management System experience adhering to ISO 13485 and ISO 1497
Experience with SAMD would be beneficial
Lead internal Auditor to ISO 13485

This is a brilliant opportunity to join a reputable consultancy with a broad range of clients allowing you to manage several projects at any one time, all while they look to grow the UK division following their expansion.

As such, you will be rewarded withcompetitive salary options with the option of fully remote working.