Regulatory Specialist

1 week ago

Castle Donington, Leicestershire, United Kingdom Medstrom Ltd Full time

Regulatory Specialist
Castle Donington, Derby

About Us
Medstrom are a UK based leading medical device service provider and manufacturer.

As an organisation, we pride ourselves for having developed a strong reputation within the healthcare industry for providing quality medical equipment and a reliable, dedicated, and trusted service to our partners across the UK and Ireland.

Guided by our core values of Respect, Teamwork, Excellence, Commitment, Integrity and Trust, we believe that our people are what makes us great.

Having recently become an Employee Ownership Trust (EOT), we are equally invested in all our employees, and as suchare offering you this excellent opportunity to develop your career with the "Medstrom family".

The EOT sustains Medstrom's independence and recognition of the fact that we are built upon the hard work and commitment of its employees and is unlike any other company in the industry.

Medstrom leadership team said, "It gives us all great pleasure to givesomething back to our very committed colleagues, as they often go above and beyond their duty to ensure our customers are well looked after.

"

We offer training opportunities, at all levels, and are willing to support and encourage individuals that want to expand their product and technical knowledge or personal development.

We are currently looking for a Regulatory Specialist to join the Medstrom team.

This is a full time role based at our newly renovated Head Office in Castle Donington (with the potential of some hybrid working once trained).


The Benefits:

  • Basic starting salary of £30,000 p.a.
  • Annual Bonus scheme
  • Contributory pension scheme
  • Flexible hybrid working
  • 33 days' holiday including Bank Holidays
  • Discounts and cashback on shopping, supermarkets and holidays as part of our rewards scheme
  • Salary Sacrifice Schemes including cycle to work
  • Receive a "treat" on your birthday
  • Be a part of an Employee Ownership Trust (EOT) and the associated benefits of having a stake in the company

The Role

As a Regulatory Specialist, you will be involved in all aspects of the development and maintenance of regulatory systems to ensure compliance to all relevant standards.


You will be responsible for:

  • Assisting in the administration of regulatory functions to ensure adherence to ISO13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards
  • Support the preparation and ongoing maintenance of medical device technical files under the EU Medical Device Regulation (2017/745) and other applicable regulatory standards
  • Identify regulatory requirements for new products or product enhancements early in the product development cycle
  • Gather information to support regulatory submissions
  • Investigate adverse incident events and ensure accurate and timely submissions to regulatory agencies
  • Review product revision requests to assure compliance
  • Work on product development teams to develop regulatory strategy
  • Review and approve labelling and marketing literature
  • Participate in internal and external audits
  • Keep informed of regulatory issues that impact Medstrom
  • Work with Quality and Regulatory Manager to identify key initiatives, which may be affected by present or emerging policies
  • Support Regulatory Affairs compliance activities as necessary
Hours of work: 37.5 hours per week, Monday - Friday

About You
To join us as a Regulatory Specialist, ideally you will need:

  • Minimum of 3 years' experience in a similar role
  • Excellent verbal and written communication skills
  • Strong interpersonal skills
  • Strong problemsolving skills
  • Excellent organisational skills
  • Highly developed attention to detail
  • Strong project management skills
  • Ability to work well in a team environment

Webrecruit and Medstrom are equal opportunities employers, value diversity and are strongly committed to providing equal employment opportunities for all employees and all applicants for employment.

Equal opportunities are the only acceptable way to conductbusiness and we believe that the more inclusive our environments are, the better our work will be.

This vacancy is being advertised by Webrecruit. The services advertised by Webrecruit are those of an Employment Agency.

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