Senior Regulatory Manager - Hitchin, United Kingdom - Atom Recruitment Ltd.

Atom Recruitment Ltd.

Verified Company

Hitchin, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Our Client is a very successful pharmaceutical company.

They are now seeking a
Regulatory Manager - Medical Devices. This position is a full-time permanent role and will be predominantly office based near
Hitchin in Hertfordshire.

Job Purpose

An opportunity has arisen for a Medical Device Regulatory Manager to join the Regulatory and Clinical Affairs team
The role will be responsible for providing comprehensive and broadranging regulatory expertise in all aspects of maintaining product regulatory compliance, as well as obtaining and maintaining medical device certification as required

Key Areas of Responsibility

Assessing, preparing, and submitting any necessary change notifications to maintain device registrations and technical files
Preparing and maintaining additional supporting regulatory documentation including product literature and technical reports
Preparing and reviewing documents to demonstrate compliance with regulatory standards, specifications, guidelines, and relevant codes of practice
Maintaining accurate and up to date regulatory documentation including controlled documents, change control records, and SOPs in accordance with the quality management system
Providing regulatory compliance guidance and support to other departments particularly Clinical Research, Pharmacovigilance, Pharmaceutical Development, Purchasing & Supply, Production, Distribution, and Sales/Marketing
Liaising and fostering constructive professional relationships within the business as well as with Regulatory Authorities, Notified Bodies, industry bodies, contract manufacturers and business partners
Managing, motivating, training, and developing a small regulatory team

Qualifications / Experience

Extensive relevant regulatory experience in medical devices (preferably substance based). This experience should ideally include handling MDD/MDR technical documentation in the UK/EU, and/or experience of the regulatory equivalents in other sectors. Upto date working knowledge of regulatory guidelines, directives and other legislation is required
Ability to take a helicopter approach
Effective verbal and written communication skills, with the ability to present complex issues in a clear, logical, and persuasive way at all levels
Confidence in both giving and defending an expert opinion
Meticulous attention to detail
Strong organisational and planning skills combined with the ability to work both independently and as part of a team, to defined deadlines
Computer competence and experience of document management systems.
Ability to problem solve and work under pressure to meet deadlines

Please send your C.V to Lorraine Roger, Director at Atom Recruitment Ltd.