Regulatory Affairs Specialist
The Regulatory Affairs Specialist 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.
- Prepare or assist in the preparation of submissions to regulatory agencies
- 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
- Experience in medical device regulatory affairs including knowledge of reporting and vigilance requirements in different territories
- Knowledge of applicable standards including but not limited to ISO 14971, IEC 62304 and ISO 13485 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
- Degree in a life science, law or appropriate engineering discipline;
- or equivalent applicable qualifications in regulatory affairs
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.