Regulatory affairs associate

Permanent
About Us

Perspectum Diagnostics delivers digital technologies that help clinicians to provide better care for patients.

Our diverse and talented team is united behind our vision to empower patients and clinicians through greater understanding of liver disease, enabling early detection, diagnosis and targeted treatment.

Patients are at the heart of our design. Our technology is convenient, non-invasive and supports patient engagement in their care by providing clear and understandable results.

We work in a friendly office in the centre of Oxford, a 5 minute walk for rail and bus links. Perspectum UK offers flexible benefits such as Share Options, Cycle to Work, Flexible Working, and Private Medical.

The Role

The Regulatory Affairs Associate liaises with the Regulatory Affairs and Quality teams, R&D and Product Management to provide regulatory input into NPI Project Core teams and company operations. They assist in the preparation and submission of regulatory applications and registrations as assigned including Design Dossier, Technical Files, 510(k)’s, CSDT files annual reports. They will assist in correspondence with review agencies, notified bodies, and trade associations on matters relating to product registrations and PMS. The Regulatory Affairs Associate will need to liaise with other departments serving as a Regulatory representative on all cross functional teams across PD, guide and monitor regulatory compliance in the various countries.

Responsibilities

Understand the relevant regulations with regards to the country of registration and support the strategy for market entry together with the relevant internal stakeholders.
Market monitoring and regulatory research for new target jurisdictions.
Maintaining compliance with relevant regulatory legislation and guidelines
Representation of regulatory affairs at project team meetings for defined projects, providing information, feedback and strategic advice
Coordination of the regulatory activities associated with project team plans
Preparation, attendance and follow up of meetings with Regulatory Agencies
Assist in preparation of regulatory submissions
Coordinate the provision of information requested by regulatory authorities
General maintenance of Quality Management System
Interface with regulatory reviewers through written and oral communications as needed
Skills and Requirements: Essential

Degree in a life science, law or appropriate engineering discipline, or an equivalent qualification in Regulatory Affairs, or equivalent experience in Regulatory Affairs
Fluency in spoken and written English
Detail oriented and excellent written and verbal communication skills
Ability to work independently
Ability to plan and manage workload
Strong interpersonal skills and the ability to work as part of a team
Ability to support employees from other teams
Detail oriented and excellent written and verbal communication skills
Skills and Requirements: Desirable

Experience in medical device or regulatory affairs
Understanding of Quality Management Systems – FDA QSR, ISO 13485
Job Types: Full-time, Permanent

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