Regulatory Affairs Associate
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.
- 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
Interested in this position?
We are always looking for brilliant people to join us here at Perspectum Diagnostics.
Use the form below to send us your application.