Regulatory Affairs Specialist

3 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

  • Regulatory Affairs Specialist

    3 months ago

    Oxford, United Kingdom Bond Williams Full time

    As Regulatory Affairs Specialist responsibilities include: - Collaborate closely with the Regulatory Affairs Manager to develop and maintain technical files and submissions for global regulators. - Utilise your regulatory expertise to support the development of regulatory strategies for product submissions. - Analyse routes to market and provide relevant...

  • Principal Regulatory Affairs Specialist

    3 months ago

    Oxford, United Kingdom Cpl Life Sciences Full time

    **Reference Number**: JO-2308-521008 Principal Regulatory Affairs Specialist **Rate**: £60,000 - 75,000 **Job Type**: Permanent **Location**: Oxford **Job Title**: Principal Regulatory Affairs Specialist **Job Type**: Permanent **Location**: Oxfordshire based **Salary**: £60,000 - £75,000 plus attractive benefits This is fantastic opportunity to...

  • Regulatory Affairs Specialist

    2 months ago

    Oxford, United Kingdom Mirada Medical Full time

    **About Mirada Medical...** Mirada Medical develops medical imaging and cancer treatment planning solutions that provide simple and accessible solutions to complex image analysis problems in the diagnosis and treatment of cancer and other diseases. Our solutions interoperate with other IT systems in the healthcare enterprise, such as EHRs and PACS,...

  • Regulatory Affairs Specialist

    3 months ago

    Oxford, United Kingdom Oxford Nanopore Technologies Full time

    **About Us** Oxford Nanopore's sequencing platform is the only technology that offers real-time analysis (for rapid insights), in fully scalable formats from pocket to population scale, that can analyse native DNA or RNA and sequence any length of fragment to achieve short to ultra-long read lengths. Our goal is to enable the analysis of any living thing,...

  • Senior Regulatory Affairs Specialist

    3 months ago

    Oxford, United Kingdom Perspectum Full time

    Senior Regulatory Affairs Specialist **About the role** 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 will assist in correspondence with review agencies, notified bodies, and trade associations on...

  • Regulatory Affairs Specialist

    3 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** 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...

  • Senior Regulatory Affairs Specialist

    1 month ago

    Oxford, Oxfordshire, United Kingdom Cpl Full time

    Senior Regulatory Affairs Specialist – Medical Devices & IVD'sOxfordshire, UK – Office based Up to £60,000 + benefits This is an excellent opportunity to join a leading medical device manufacturing that is the world leader in Glucose Monitoring, their ranging product portfolio, develops and manufactures glucose monitoring systems for use in both home...

  • Regulatory Affairs Specialist

    5 days ago

    Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full time

    Job DescriptionOxford Nanopore Technologies is a leading biotechnology company that specializes in the development and commercialization of innovative sequencing technologies. As a Post Market Surveillance Manager, you will play a critical role in ensuring the quality and safety of our products.Key ResponsibilitiesCoordinate post-market surveillance...

  • Regulatory Affairs Specialist

    3 months ago

    Oxford, United Kingdom Adaptix Full time

    **Description**: **Want to be part of a team transforming healthcare?** We are looking for an experienced **Regulatory Affairs Specialist **to join us at an exciting time as we transfer our world-leading technology from R&D to manufacture. Working within the Quality and Regulatory team, you will be responsible for ensuring compliance with applicable...

  • Regulatory Affairs Associate

    9 hours ago

    Oxford, United Kingdom Cure Talent Full time

    Cure Talent is thrilled to partner with a leading Medical Devices Manufacturer, who due to continued growth, has an exciting opportunity for an experienced Regulatory Affairs Associate to join their team.As the new Regulatory Affairs Associate, you will be responsible for supporting global product registrations, maintaining design dossiers, and ensuring...

  • Regulatory Affairs Director

    5 days ago

    Oxford, Oxfordshire, United Kingdom SciPro Full time

    **About SciPro**We are a leading provider of innovative medical solutions, specializing in AI-powered imaging biomarkers. As an exclusive partner of Brainomix, we are committed to delivering high-quality products that meet the highest regulatory standards.**Job Summary**We are seeking a highly experienced Senior Quality Assurance Manager to join our team. As...

  • Regulatory Affairs Associate

    4 hours ago

    Oxford, United Kingdom Cure Talent Full time

    Cure Talent is thrilled to partner with a leading Medical Devices Manufacturer, who due to continued growth, has an exciting opportunity for an experienced Regulatory Affairs Associate to join their team.Submit your CV and any additional required information after you have read this description by clicking on the application button.As the new Regulatory...

  • Senior Manager of Regulatory Affairs

    2 weeks ago

    Oxford, United Kingdom WALKER COLE INTERNATIONAL LTD Full time

    Walker Cole is seeking a Senior Manager of Regulatory Affairs to join a clinical-stage biopharmaceutical company based in the South of England. This position has become available for a European and UK Regulatory Lead to oversee regulatory strategy for immunotherapeutic products at all development stages. Key responsibilities include creating plans for...

  • Director of Regulatory Affairs

    2 months ago

    Oxford, Oxfordshire, United Kingdom Cpl Full time

    Job Title: Director of Regulatory Affairs (CMC)Location: Oxfordshire, United Kingdom Salary: Attractive salary plus benefits package (stock options, car allowance, bonus)Job Type: Full time, permanent positionWorking for one of the industry's most innovative clinical stage biotechnology companies, this is a fantastic opportunity to provide expert regulatory...

  • Regulatory Affairs Manager

    3 days ago

    Oxford, Oxfordshire, United Kingdom SciPro Full time

    SciPro is proud to be an exclusive partner of Brainomix, a renowned business specializing in AI-powered imaging biomarkers. To facilitate their journey of growth, they are seeking a Senior Quality/Regulatory Manager to oversee a team of 5, who is able to promote collaboration rather than adopting a dictatorial approach. The ideal candidate will have a...

  • Regulatory Affairs Manager

    5 days ago

    Oxford, Oxfordshire, United Kingdom SciPro Full time

    SciPro is proud to be an exclusive partner of Brainomix, a renowned business specializing in AI-powered imaging biomarkers. To facilitate their journey of growth, they are seeking a Senior Quality/Regulatory Manager to oversee a team of 5, who is able to promote collaboration rather than adopting a dictatorial approach. The ideal candidate will have a...

  • Senior Manager, Regulatory Affairs Medical Devices

    1 day ago

    Oxford, Oxfordshire, United Kingdom SciPro Full time

    Job Title: Senior Manager, Regulatory Affairs Medical DevicesJob Summary:We are seeking a highly experienced Senior Manager, Regulatory Affairs Medical Devices to join our team at SciPro. As a key member of our organization, you will be responsible for overseeing the regulatory affairs function for our medical devices.Key Responsibilities:Oversee the...

  • Senior Manager, Regulatory Affairs Medical Devices

    1 day ago

    Oxford, Oxfordshire, United Kingdom SciPro Full time

    Job Title: Senior Manager, Regulatory Affairs Medical DevicesJob Summary:We are seeking a highly experienced Senior Manager, Regulatory Affairs Medical Devices to join our team at SciPro. As a key member of our organization, you will be responsible for overseeing the regulatory affairs function for our medical devices.Key Responsibilities:Oversee the...

  • Senior Director, Regulatory Affairs

    2 months ago

    Oxford, Oxfordshire, United Kingdom Cpl Full time

    Job Title: Senior Director, Regulatory Affairs Location: Oxfordshire, United Kingdom Salary: Attractive salary plus benefits package (stock options, car allowance, bonus)Job Type: Full time, permanent positionWorking for one of the industry's most innovative clinical stage biotechnology companies, this is a fantastic opportunity to provide expert regulatory...

  • Public Affairs Specialist

    3 days ago

    Oxford, Oxfordshire, United Kingdom Membership Bespoke Full time

    About the RoleWe are seeking a highly motivated and detail-oriented Policy Assistant to join our team at Membership Bespoke. As a Policy Assistant, you will play a key role in supporting our client, a well-respected trade association, in monitoring, researching, and communicating on public policy, political, and other issues impacting the sector.Key...