Regulatory Affairs Specialist, SME
|Contact Name:||Larry O’Leary|
Our client, a Medtech company based in Galway, now seeks a Regulatory Affairs Specialist to support the product development process, submissions, maintenance of regulatory files and regulatory compliance.
The successful candidate will work as part of a team responsible for Regulatory Activities with specific responsibility for high-end medical device products.
This hire will Includes preparation and review of technical and process information for global submission activities as well as for change orders, working closely with R&D, DA and Operations groups.
Responsibilities of Regulatory Affairs Specialist, SME:
Provide support to the core team on all aspects of regulatory strategy for Medtech products including development and execution of plans.
Review and approve documentation related to product release.
Provide input, review and approve facility regulatory activities such as labelling.
Provide updates on regulatory requirement changes, either on individual product specification or quality systems.
Understands and proactively follow through on the Environmental Management Procedures that have been identified as relevant to position.
Understand and implement the Product Lifecycle processes in particular sustaining activities.
Participates in Regulatory Body audits such as FDA, DEKRA, HPRA.
Requirements of Regulatory Affairs Specialist:
Level 8 HETAC qualification in Science or Engineering discipline.
3+ years relevant regulatory affairs industry experience.
Good interpersonal, communication and teamwork skills essential.
Previous experience within Regulatory Affairs would be an advantage.
Ability to communicate with people at all levels, in cross-functional environment.
For further details, please contact Larry on 01-2302400 / firstname.lastname@example.org
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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