Regulatory Affairs Specialist

5 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

    5 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

    6 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

    6 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

    5 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

    6 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...

  • Regulatory Affairs Director

    1 month ago

    Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full time

    Job SummaryOxford Nanopore Technologies is a leading developer of innovative DNA sequencing technologies. We are seeking a highly experienced Senior Director, Regulatory Affairs to join our team in Oxford, UK.The successful candidate will be responsible for ensuring the firm's compliance with regulatory requirements in the territories in which our IVD...

  • Regulatory Affairs Director

    1 month ago

    Oxford, Oxfordshire, United Kingdom https:jobs-redefined.cositemap Full time

    Senior Director Regulatory AffairsOxford Nanopore Technologies is a leading developer of nanopore-based next-generation sequencing technology. The company is headquartered in the UK and has a global presence with offices and commercial operations in multiple locations across the US, APAC, and Europe.The Senior Director Regulatory Affairs will be responsible...

  • Regulatory Affairs Specialist

    1 month ago

    Oxford, Oxfordshire, United Kingdom Lenntech Search Full time

    LennTech Search is partnering with a pioneering software medical device company to find an experienced Regulatory Affairs Manager.Main ResponsibilitiesLead the company's regulatory submissions to the FDA, ensuring compliance with all applicable regulations.Prepare and submit applications and reports to regulatory agencies, leveraging expertise in medical...

  • Regulatory Affairs Director

    1 month ago

    Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full time

    About UsOxford Nanopore Technologies is a leading company in the field of sequencing technology, with a presence in multiple global locations. The company employs experts from various fields, including nanopore science, molecular biology, and informatics.The Senior Director of Regulatory Affairs will be responsible for ensuring the company's compliance with...

  • Regulatory Affairs Expert

    4 days ago

    Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full time

    At Oxford Nanopore Technologies, we're seeking an experienced Regulatory Affairs Expert to ensure our products meet global regulatory standards. The ideal candidate will have a strong background in managing regulatory processes and overseeing Quality Management Systems.The estimated salary for this role is $120,000 - $180,000 per year, depending on location...

  • Regulatory Affairs Specialist

    6 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 Director

    4 weeks ago

    Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full time

    Oxford Nanopore Technologies is a leading developer of innovative sequencing technologies. As a key member of our team, you will play a critical role in ensuring the company's products meet the highest regulatory standards.Key ResponsibilitiesManage the Regulatory, Risk Management, PMS and Clinical Affairs functions to ensure compliance with regulatory...

  • Regulatory Compliance Specialist

    4 days ago

    Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full time

    Oxford Nanopore Technologies, a leading company in the diagnostics industry, is seeking a Regulatory Compliance Specialist to join their team. This role will be responsible for coordinating all required post-market activities, ensuring compliance with international regulations and OND Quality Management System (QMS) policies.The successful applicant will...

  • Senior Director Regulatory Affairs Lead

    4 weeks ago

    Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full time

    About UsOxford Nanopore Technologies is a leading developer of real-time nanopore-based DNA/RNA sequencing technology. Our goal is to enable the analysis of any living thing, by anyone, anywhere. We offer a range of products and services that cater to various needs, from research to clinical applications.Job SummaryWe are seeking a highly experienced Senior...

  • Regulatory Affairs Officer

    3 days ago

    Oxford, Oxfordshire, United Kingdom OXB Full time

    Role Summary:We are looking for a skilled Regulatory Affairs Officer to join our team at OXB.The successful candidate will be responsible for ensuring GMP compliance, supporting QC testing, and managing QC database.Key Tasks:GMP ComplianceQC Testing SupportQC Database ManagementQuality Record ManagementAbout OXB:Leader in viral vector development and...

  • Regulatory Affairs Manager

    1 day ago

    Oxford, Oxfordshire, United Kingdom OrganOx Full time

    OrganOx is a pioneering medical device company that's transforming the field of organ transplantation. We're looking for a talented Regulatory Affairs Manager - Complaints to join our dynamic team.In this role, you'll be responsible for managing regulatory activities, reporting directly to the Global Director RA/QA. Your primary focus will be on ensuring...

  • Government Affairs Director

    4 weeks ago

    Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full time

    Job SummaryThe Government Affairs Director will support the Corporate Affairs team by driving global government affairs and collaborating with the wider team in corporate communications and internal communications. This role will align with Oxford Nanopore's key priorities, resulting in increased awareness, understanding, and collaboration with the company,...

  • Regulatory Affairs Director for Medical Device Industry

    3 days ago

    Oxford, Oxfordshire, United Kingdom Lenntech Search Full time

    LennTech Search is a recruitment agency working with innovative software medical device companies. We have an exciting opportunity for an experienced Regulatory Affairs Manager to join our client's team.Key ResponsibilitiesLead the company's regulatory submissions to the FDA, ensuring compliance with all relevant regulations and guidelines.Prepare and submit...

  • Government Affairs Expert

    6 days ago

    Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full time

    About the RoleAre you a seasoned professional with expertise in government affairs and international relations? Do you have a passion for working in a fast-paced environment, driving global engagement and collaboration with governments and regulatory bodies?We are seeking an experienced Government Affairs Expert to join our team at Oxford Nanopore...

  • Market Surveillance and Regulatory Compliance Specialist

    1 month ago

    Oxford, Oxfordshire, United Kingdom https:jobs-redefined.cositemap Full time

    Oxford Nanopore Technologies is a leading company in the field of genetic analysis, headquartered at the Oxford Science Park in the UK. We have a global presence with satellite offices and commercial operations in the US, APAC, and Europe.This role reports to the Regulatory Affairs Manager and is responsible for coordinating post-market activities. The...