Regulatory Affairs Specialist

Are you and RA Specialist looking for your next role in an exciting new team?
As Regulatory Affairs Specialist you will liaisewith the Regulatory Affairs and Quality teams, R&D and Product Management to provide regulatory input into NPI Project Core teams and company operations. 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.
Youwill assist in correspondence with review agencies, notified bodies, and trade associations on matters relating to product registrations and PMS. The Regulatory Affairs Specialist will need to liaise with other departments on all cross-functional teams across PD, guide and monitor regulatory compliance in the various countries.
Duties and Responsibilities
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.
Person Specification
Training/Certifications in ISO 27001 Information Security
ISO 13485 internal auditor training
An engaged member of TOPRA and/or RAPS
Excellent written and spoken communication skills
Excellent attention to detail
Effective time management and working to deadlines
Ability to effectively prioritise tasks and manage their own workload
Strong interpersonal skills and ability to work independently and as part of a team
Ability to work with and support other teams in the business
Effective analytical and problem solving skills
Experience working in a regulated environment, preferably in the lifesciences industry
About Us
At Perspectum, we offer our employees a flexible, fast-paced, and fun environment. We are driven by hiring the best talent, who share our values of excellence, accountability, integrity, openness, and passion. We value our employees and are constantly striving to ensure we provide a working environment that offers something for everyone, whether that be flexible working, training opportunities or health and wellbeing initiatives. Benefits include:
33 days annual leave (inclusive of Bank Holidays), increasing with service.
Discretionary bonus scheme.
Private healthcare including medical referrals, discounts, access to counselling and nutritional support, and cashback on healthcare bills.
Share options.
Life assurance.
Pension contribution rising to 6% after 2 years’ service.
Sociable working environment including pool table, table tennis and table football.
£30 per month for gym membership, via GymFlex.
Hybrid working – we like our employees to be in the office 3 days per week to build those all-important relationships.
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