RIM Specialist - (Medical Devices)

If you are an experienced Medical Device Regulatory Affairs professional with current knowledge of the broad range of RA activities. Someone with ambition and drive, a problem-solver and a clear, concise communicator who can deliver high quality results then consider a Regulatory Information Specialist position with Instem.

 

Our customers, our team and our market are global, so we can be flexible about your work location, but you need to be able to travel regularly for business.

 

We are looking for someone who can combine a deep understanding of Regulatory Affairs with the commercial ability and communication skills to enable our customers to maximise the value they receive from our solution.

 

We need your help to develop and grow our position in the MedDev RIM world as leaders. You will be largely the "face of Instem" in this market, giving presentations to industry groups, prospects and customers, engaging with industry bodies on MedDev RIM topics and helping to shape our messages and themes. In addition, they will provide input to our product managers on content and priorities for our products and services, participate in sales activities and deliver occasional paid-for consultancy.

 

 

As a RIM Specialist at Instem you can expect to:

  •       To deliver consultancy.
  •       To work with our Sales and Marketing teams to help craft and deliver industry-leading messages to our prospects, customers and the wider market.
  •       To act as a source of knowledge and experience for our product team, helping to shape our roadmap and product content.
  •       To participate and contribute to industry events and bodies, keeping us and our customers informed of developing regulatory changes.
  •       Undertake fairly frequent overseas travel, sometimes alone.

 

We are looking for:

An experienced Regulatory Affairs professional with current knowledge and experience of the broad range of RA activities from a medical devices perspective and with experience of using RIM solutions.

The successful candidate is likely to be educated to degree level with a current understanding of all aspects of Regulatory Affairs in a medical device company.

Ideally experience in MedDev Vigilance or experience of registration and tracking activities in a multi-product, global organisation.

Experience of working with, at least, FDA and EMA regulatory requirements.

Experience of working across all classes of device.

 

 

The Package:

• Excellent Starting Salary

• Private group medical insurance

• Life Assurance

• Opportunities for career progression

• On-going Training

 

 

Apply today and learn more about how along with us, you can help our customers bring life enhancing products to market faster.

 

The Samarind RMS suite is a fully integrated software solution that has been purpose built to mirror the processes associated with acquiring and maintaining product licenses.

 

Samarind RMS provides a smarter way to manage your Medical Product Information. Using Samarind RMS, you only need to enter data once and can reuse it as many times as required. For example an ‘INN’ can be entered once and reused for all related IMA submissions, renewals, variations, PSURs and XEVMPD submissions. This concept applies to all key data held within the system and is proven to streamline workflows and help to increase data quality.

 

"Instem is a global provider of leading software solutions and services that are helping over 500 clients bring their life enhancing products to market faster. We enable clients in the life sciences to more efficiently collect, analyze, report and submit high quality regulatory data, while maintaining compliance for their products around the world.

 

Instem stores and processes date using an Applicant Tracking System, for more information regarding our privacy policy use the following link:  http://www.instem.com/about/data-protection.php

In this policy, you will find information about our compliance with GDPR (data protection law.) You can find how to send us a request to let you access your data that we have collected, request us to delete your data, correct any inaccuracies or restrict our processing of your data.