Regulatory Affairs Specialist

Our dedicated Regulatory Affairs Department are looking to expand their department due to exciting growth within the organisation.

As Regulatory Affairs Specialist you will 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. You will assist in correspondence with review agencies, notified bodies, and trade associations on matters relating to product registrations and PMS.

This is a great opportunity to liaise with other departments on all cross-functional teams across Perspectum. You will guide and monitor regulatory compliance in various countries including UK, US and Singapore.

Your main duties will be to:

• Comprehend relevant standards to the products and services that Perspectum complies with, e.g. IEC 62304, IEC 62366
• Ensure company quality policies, processes and procedures are conformant to applicable standards and regulations
• Comprehension and general maintenance of the Information Security Management system
• Comprehension and accurate maintenance of the Quality Management System
• Work with department managers to ensure best practice and drive continuous improvements
• Communicate and roll out improved/ new processes and procedures to wider business and external stakeholders
• Be able to write partial or parts of technical documentation submissions without supervision
• Market monitoring and regulatory research for new target jurisdictions
• Assist in maintaining compliance with relevant regulatory legislation and guidelines in various territories
• Standards and regulations monitoring in the jurisdictions that Perspectum makes devices available on the market
• Conduct staff training on regulatory affairs concepts, guidance and regulations
• Coordinate the provision of information requested by regulatory authorities
• Understand the relevant regulations with regards to the country of registration and support the strategy for market entry together with the relevant internal stakeholders
• Identify and coordinate investigations arising from regulatory non-conformities
• Manage device listings in territories where Perspectum makes devices available in those markets
• Manage the transfer of regulatory technical documentation submission process to various territories
• Assist in preparation of regulatory technical documentation submissions to various territories
• Be able to efficiently communicate Adverse/Reportable Events to regulatory authorities if needed and effectively follow-up to conclusion for such events

It is essential that you hold a degree in a scientific/engineering discipline as well as experience working in a regulated environment, preferably in the life sciences industry. You will have excellent written and spoken communication skills with high levels of attention to detail. You will be an effective time manager and prioritiser with ability to work to tight deadlines, managing your own workload. You will ne analytical and a good problem solver.

Above all you will thrive in a fast paced, dynamic working environment with ability to work autonomously as well as part of a team.