Quality , Science, Pharmaceutical & Food
Senior Regulatory Affairs Associate (Remote)
- Southern England
PE Global is currently recruiting for a Senior Regulatory Affairs Associate for a leading multi-national Healthcare client. The successful candidate will be able to work remotely from within the UK
This is an initial 12 month contract with strong possibility of extension.
The purpose of this role is to 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, with emphasis on regulatory compliance and life cycle strategy.
- 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 to the client.
- 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 are met.
- Support the maintenance and planning activities related to CE and UKCA marking of medical devices.
- Provide direction to all the client’s Medical device legal manufacturers with regards to CE and UKCA marking of medical devices.
- Support the client and other legal manufacturers in CE and UKCA mark related regulatory activities in front of the Notified Bodies, UK Approved Bodies and relevant Competent Authorities.
- Degree in engineering or life sciences
- Around 3-5 years of experience preferably in Regulatory Affairs, Quality Assurance R&D or System, Standard Compliance testing in a medtech company.
- Good knowledge of CE marking of medical devices. (MDD 93/42/EEC and related directives and guidelines).
- Ability to liaise with the different functions involved in the elaboration of CE files, Manufacturing, Quality Assurance, R&D, Medical Affairs, Logistics.
- Ability to interpret European and UK regulations and guidelines and all technical product information in order to assure that regulatory requirements in the area of medical devices are continuously met.
- Excellent interpersonal and collaboration skills and willingness to work in a challenging regulatory environment.
- Excellent organizational skills including project management skills.
- Strong commitment to teamwork, quality and customer satisfaction.
- Excellent written and verbal communication skills in English.
- Cultural sensitivity.
- Accountable for anticipating and resolving problems.
- Accountable for completion of submissions in a shortest possible time-to-market.
- Accountable for the compliance of submitted files with the corporate standards.
- Open to innovation and risk taking.
Interested candidates should submit an updated CV.
Please click the link below to apply or alternatively send an up to date CV to Jennifer.firstname.lastname@example.org
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***