Posted: 11h ago
The role
Main Duties
Assist in the preparation, compilation and submission of premarket regulatory documentation, including EU IVDR submission, 510(k) submissions and other international filings, ensuring accuracy, completeness and adherence to regulatory requirements.
Review, maintenance and approval of technical documentation of the companys products, in compliance with the relevant regulations and standards.
Review complaints, CAPAs and non-conformances for regulatory reporting for CE-IVD marked products.
Assist in preparation, maintenance and approval of Risk Management and Post Market Surveillance Files.
Review and approval of artwork (labels, instructions for use) for compliance with applicable regulatory requirements and international standards.
Review change controls for impact on regulatory compliance.
Monitor changes in legislation, standards and guidance documents related to the companys products and communicate findings to cross functional teams as required.
Assist in distribution process to ensure regulatory compliance.
Support regulatory audits and inspections.
Maintain appropriate regulatory records.
Review and approve internal and external queries and requests.
Collaborate effectively with cross functional teams such as Quality and R&D to gather necessary information and align regulatory activities with product development milestones.
Essential Criteria
BSc in Molecular Biology or a relevant discipline.
Minimum 3 years' experience working in a regulatory role for a Medical Device or In Vitro Diagnostic Company.
Experience in reviewing and approving technical documentation as per EU/US regulations.
Good working knowledge of ISO 13485, ISO 14791 and IVDR/MDR.
Ability to manage competing priorities in a fast-paced environment.
Ability to work to tight deadlines.
Good initiative and team player.
Strong writing, verbal and interpersonal skills.
Desirable Criteria
Experience supporting product launches in new markets.
Experience in audits or inspections.
Experience in health authority interactions.
Desired Skills and Experience
Regulatory Affairs
IVDR
Medical Device
ISO13485
ISO 14971
EU MDR
CAPAs
Complaints
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