Walker Cole is searching for a Regulatory Affairs Specialist to join a dynamic team at a global genomic solutions provider in the Southeast of England.
As a Regulatory Affairs Specialist you will:
* Work within a positive, dynamic culture, focused on growth. Providing input and technical guidance to develop teams.
* Work within global markets, maintaining knowledge of the company’s portfolio.
* Liaise with key stakeholders, Authorised representatives, 3rd parties, international regulatory agencies, and product managers.
* Maintain submission documents, review labelling and promotional items.
* Review and authorise technical documentation, generate and review risk management documentation, develop and maintain post-marketing surveillance activities and develop regulatory submission strategies.
A Regulatory Affairs Specialist will be/have:
* Degree level/equivalent in Life Sciences
* Experience in IVD and/or medical device regulation, preferably EU-related
* A dynamic, proactive individual with a focus on personal and professional growth.
Desirables in a Regulatory Specialist:
* Experience with ISO 13485, as well as 21 CFR Part 820
* Post-market surveillance activities, vigilance and recall experience
* Has dealt with Competent Authorities, global regulators and notified bodies.
Regulatory Affairs Specialist // IVD //Medical Device // Genomics // Post-Marketing // Submissions // Review // Labelling // Global // Vigilance // Promotional // Authorisation // Strategies // Regulatory Affairs