Regulatory Manager Full-time, permanent position Reporting to the Chief Operations Officer My client have a requirement for a Regulatory Manager who will drive and manage the regulatory team ensuring the company is compliant in all regulatory and legal requirements.
Main Duties: Guide, coach, direct and develop direct reports.
Determine team priorities and resolve any conflicts for department resources.
Conduct project/team meetings regularly to ensure work programs are tracking to plan, providing information and input, assigning work and resolving any issues.
Oversee the regulatory strategy implementation and control within the regulatory team.
Manage and maintain technical documentation for existing Class A and B IVD products, including technical review of documents.
Manage the internal post-market surveillance and risk management processes.
Coordination of vigilance reporting for CE-IVD, & any other approved territory reporting ensuring all regulatory reporting timelines are met.
Manage and maintain existing regulatory clearance/certification and filings in new territories.
Manage regulatory submission timelines, identify risks and appropriate mitigations.
Advise on regulatory strategies for existing, changing and non-conforming products in collaboration with R&D, Manufacturing and Technical departments, as appropriate.
Maintain knowledge of current regulatory environment in relevant markets to ensure that information is adequately communicated throughout the company relating to changes in the regulatory environment.
Act as deputy Person Responsible for Regulatory Compliance, as required.
EssentialCriteria: BSc in Molecular Biology or a relevant discipline.
Minimum 5 years experience working in a regulatory role for a Medical Device or In Vitro Diagnostic Company.
At least 2 years experience managing, or supervising team members.
Excellent working knowledge of ISO ***** and IVDR/MDR.
Ability to manage competing priorities in a fast-paced environment.
Strict attention to detail in all aspects of the role.
Ability to interact professionally with all organisation levels.
Excellent communication and interpersonal skills.
DesirableCriteria: Knowledge and understanding of software as a medical device and associated guidance and standards.
Experience engaging with Notified Bodies or international Regulatory Authorities during conformity assessment process.
Skills: regulatory affairs medical affairs Manager regulatory manager