Regulatory Affairs Specialist

4 months ago

Oxford, United Kingdom Perspectum Full time

Are you an experienced Regulatory Affairs Specialist looking for your next role in an exciting new team?

**About the Role**

Day to day you will assist in correspondence with review agencies, notified bodies, and trade associations on matters relating to product registrations and PMS. You will liaise with other departments on all cross-functional teams across Perspectum, guide and monitor regulatory compliance in the various countries. Your duties and responsibilities will also include:

- Maintain relevant standards to the products and services that Perspectum complies with, e.g. IEC 62304, IEC 62366, ensuring company quality policies, processes and procedures are conformant to applicable standards and regulations.
- Accurately maintain the Information Security Management and Quality Management systems.
- Work across the organisation to ensure best practice and drive continuous improvements.
- Communicate and roll out improved/ new processes and procedures to wider business and external stakeholders.
- 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 Perspectum's jurisdictions.
- Conduct staff training on regulatory affairs concepts, guidance and regulations
- Understand 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.
- Assist in preparation and manage the transfer of regulatory technical documentation submission process to various territories.
- Efficiently communicate Adverse/Reportable Events to regulatory authorities if needed and effectively follow-up to conclusion for such events.

**About You**

You will be experienced within Medical Devices Regulatory Affairs and have sound understanding of certifications such as ISO13485 and ISO 27001. Above all you will want to join a dynamic, fast paced medical devices organisation who is on a mission to revolutionise patient diagnostic journeys. Your skills will include:

- Ability to write partial or parts of technical documentation submissions without supervision
- 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

**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
- Electric Vehicle 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 Oxford office 3 days per week to build those all-important relationships

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