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Regulatory Affairs Senior Associate

Employer
i-Pharm Consulting
Location
Homeworking
Salary
GBP40.00 - GBP45 per hour
Start date
24 Nov 2022
Closing date
8 Dec 2022

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)
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Job Details

Regulatory Affairs Consultant - Medical Devices

Home based UK

12 month contract

£45 per hour maximum pay (inside IR35)

37.5 hours per week

Global Medical Device company


Summary


Support the management of CE marking activities (MDD 93/42/EEC and MDR 2017/745) and UKCA marking activities (UK Medical Device Regulations 2002) for medical devices from all Global Business Unites (GBUs), with emphasis on regulatory compliance and life cycle strategy.

Essential Duties and Responsibilities


  • Support the development/alignment of regulatory policies and strategies across all GBUs
    * Working with cross-functional groups to ensure the development of regulatory strategies for the CE and UKCA marking of new Medical Devices in accordance with the business goals.
    * Support development of strategic plans for submissions and authority interactions.
    * Participate in regional Industry Association meetings (including MedTech EU working groups).
    * Interpret existing, pending and proposed regulations/guidance documents regarding MDD, MDR and UKCA - providing assessment on impact.
    * Supports the Legal Manufacturer in its fulfilment of its regulatory responsibilities under the MDD, MDR and UKCA.
    * Support the implementation of the RA management systems (incl. relevant SOPs) to ensure the regulatory requirements of are met.
    * Support the maintenance and planning activities related to CE and UKCA marking of medical devices.
    * Provide direction to all Medical device legal manufacturers with regards to CE and UKCA marking of medical devices.
    * Support in CE and UKCA mark related regulatory activities in front of the Notified Bodies, UK Approved Bodies and relevant Competent Authorities.

Qualifications

  • Degree in engineering or life sciences

Key Skills and Experience

* Around 3-5 years of experience in Medical Device Regulatory Affairs.
* Good knowledge of CE marking of medical devices. (MDD 93/42/EEC and related directives and guidelines).

Company

i-Pharm Consulting provides Talent Solutions for the global Life Sciences sector.

We are an award-winning international life sciences recruitment company with offices in London, Munich, Frankfurt, Sydney, New York, Charlotte, and Los Angeles. In a highly competitive marketplace, we connect top talent with the very best opportunities.

Since 2008, i-Pharm’s independent, expert, and ethical approach to procuring talent has helped power the pioneering progress made by Pharmaceutical, Biotech and MedTech companies around the world. 

With offices across 3 continents, we have teams servicing the major global life science hubs. We combine local knowledge, with a global network of contacts that allows us to bring together talent and opportunity when it matters most.

For candidates, we become “career partners”. We know them as people, not CVs, learning about their aims, motivations and personal situation. We build open dialogue, provide honest advice and offer ongoing support, whether or not we’re currently working with them. ​

As a result, we have supported many specialists in this focused field throughout their careers, helping them plan their path through life sciences by identifying the right roles for them, not just any roles to suit us.

We change the lives and trajectory of our candidates' careers by offering incredible opportunities with the best clients in the sector.

 

Find Us
Website
Telephone
+44 (0) 20 3189 2299
Location
52 Bedford Row
London
England
WC1R 4LR
GB
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