Commercial and Regulatory Affairs Specialist

3 weeks ago

Cambridge, United Kingdom Orion MedTech Ltd Full time

The Commercial and Regulatory Affairs Lead will serve as a key figure in navigating the landscape of regulatory compliance for medical technologies, thereby enabling successful research, development, and commercialisation of innovative healthcare solutions from inception to implementation for academic, clinical and SME stakeholders.

This role requires an individual with a comprehensive understanding of regulatory compliance in medical technologies with particular emphasis on the UK and Europe, relevant experience in regulatory affairs, routes to commercialisation (particularly within the NHS), proficiency in collaborative settings, and the ability to navigate complex stakeholder environments while ensuring adherence to regulatory standards.

**Key responsibilities**:

- Serve as a point of expertise for clinicians, academics, and SMEs on regulatory and commercialisation matters relating to medical technologies.
- Build and maintain strong relationships with external stakeholders and potential clients to foster collaboration and partnership opportunities.
- Offer guidance and direction, engaging with complex groups of suppliers and stakeholders to ensure successful project and product delivery within regulatory frameworks.
- Present complex, sensitive and/ or contentious information to stakeholders, whilst maintaining confidentiality as appropriate.
- Support the introduction of an ISO 13485 compliant QMS to support Orion MedTech and potential future projects.
- Support the implementation and progress of new and existing projects ensuring they are executed efficiently and effectively within current regulatory frameworks.
- Provide guidance and support routes to commercialisation for novel MedTech innovations, taking into account both regulatory and commercial feasibility.
- Provide comprehensive support ensuring regulatory adherence for new technologies and solutions involving MedTech and Medical Devices.
- Drive the adoption of technologies within healthcare practice, including the NHS, by ensuring robust compliance with regulatory requirements.
- Maintain specialist regulatory knowledge and expertise in medical technology adoption within healthcare, and the NHS in particular.
- Continuously monitor changes to the UK Regulatory environment and provide an impact assessment on changes to the current framework and/or implementation of new regulations.
- Prepared to undertake and complete tasks outside of their job description as may reasonably be expected from the postholder’s role, skills, and experience.

**Person Specification**:
Education and Qualifications:

- PhD (or equivalent) in a relevant area (desirable)
- (Working towards) post-graduate qualification in Regulatory Affairs or a Quality Management discipline
- Evidence of continued personal and professional development

**Experience**:

- Experience working within regulatory requirements and with regulators in the UK, to support academic and clinical studies of medical technologies
- Experience in ensuring the successful delivery of outputs, engaging, and directing complex groups of suppliers and stakeholders
- Experience working within a QMS framework for product development
- Experience in the operation of a QMS including Audit.
- Previous experience and understanding of issues relating to medical technologies translation in academia and healthcare
- Leadership experience guiding teams through regulatory processes and commercialisation
- Experience preparing technical documentation for MHRA submission

Knowledge:

- Knowledge of ISO standards including 14155, 20916, 13485, 27001 and 14971
- Knowledge of UK regulations related to medical devices including UKCA/CE marking
- Understanding of healthcare procurement processes, including the current framework within the NHS, and broader knowledge and understanding of the commercial healthcare landscape

**Skills**:

- Able to write, review, and update relevant regulatory policies, procedures, plans and strategies
- Understanding of and commitment to the principles, practices and promotion of equality and diversity.
- Demonstrated capability to plan over short-, medium-, and long term timeframes and adjust priorities accordingly
- Organisational skills and personal effectiveness
- Positive and flexible attitude
- Self-motivated
- Able to work constructively with individuals in other stakeholders within and outside the organisation including professionals/academics
- Good judgement and problem solving skills when working in a pressurised environment
- Ability to work on own initiative and organise own workload without supervision working to tight and often changing timescales

Applicants must have the right to work in the UK.

**Salary**: £35,000.00-£45,000.00 per year

**Benefits**:

- Company pension
- On-site parking
- Work from home

Schedule:

- Monday to Friday

Work authorisation:

- United Kingdom (required)

Work Location: Hybrid remote in Cambridge

  • Regulatory Affairs Specialist

    1 month ago

    Cambridge, United Kingdom Vector Recruitment Limited Full time

    Regulatory Affairs Specialist £45k-£55k (dep on exp) Cambridge We have a brand-new vacancy for a Regulatory Affairs Specialist to join a fascinating Cambridge based R&D technology company. This business is very well established and is undergoing rapid growth due to the impact that their market disruptive technology is having on the medical...

  • Quality and Regulatory Affairs Specialist

    4 days ago

    Cambridge, United Kingdom Biochrom Full time

    Biochrom is part of Harvard Bioscience (HBIO), a global business providing life science, laboratory apparatus worldwide. Reporting to Biochrom QRA Manager, the **Quality and Regulatory Affairs Specialist** (QRA Specialist) supports our _in-vitro_ diagnostic product registrations, timely undertaking of post market surveillance as well as monitoring...

  • Regulatory Affairs Specialist

    4 days ago

    Cambridge, United Kingdom ProductLife Group Full time

    About the job In the context of our growing activities, we are looking for a Regulatory Affairs Specialist to join our teams in the United Kingdom. You will integrate a team of dedicated Regulatory Affairs professionals and will have the mission to develop PLG’s local UK Regulatory Affairs presence, taking responsibility for new regulatory...

  • CMC Regulatory Affairs Contract Biologics 12 MONTH

    3 days ago

    Cambridge, United Kingdom Hays Specialist Recruitment Limited Full time

    Your New Company:Join this renowned biopharmaceutical organisation dedicated to developing innovative therapies that improve patients' lives. Leaders in the industry and looking for a biologics CMC Regulatory Affairs contractor on a 12-month assignment.Your New RoleI am seeking a Regulatory Affairs Manager - CMC (Biologics) for a 6-month contract for my...

  • Regulatory Affairs Manager

    2 weeks ago

    Cambridge, United Kingdom Hays Full time

    Your New Company:Join this renowned biopharmaceutical organisation dedicated to developing innovative therapies that improve patients' lives. Leaders in the industry and looking for a biologics CMC Regulatory Affairs contractor on a 12-month assignment.Your New RoleI am seeking a Regulatory Affairs Manager - CMC (Biologics) for a 6-month contract for my...

  • Associate Director

    4 weeks ago

    Cambridge, United Kingdom Gilead Sciences International, Ltd. Full time

    Description Regulatory Affairs Associate Director Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987, that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. Together we deliver life-saving therapies to patients in need. With...

  • Regulatory Affairs Associate Ii

    1 month ago

    Cambridge, United Kingdom Proclinical Full time

    Proclinical are recruiting for a Regulatory Affairs Associate II to join a pharmaceutical organisation. This role is on a contract basis and is located in Cambridge/Uxbridge with hybrid working available. **Key Skills and Requirements**: - Administration familiarity within a corporate or similar business setting, preferably within a healthcare sector. -...

  • Regulatory Affairs Associate

    1 month ago

    Cambridge, United Kingdom Proclinical Full time

    Proclinical are recruiting for a Regulatory Affairs Associate - II to join a pharmaceutical organisation. This role is on a contract basis and is located in either Cambridge or Uxbridge with hybrid working available. **Responsibilities**: - Conduct workflows and processes concerning document tracking, indexing, retrieving, and disseminating information to...

  • Regulatory Affairs Manager

    1 week ago

    Cambridge, Cambridgeshire, United Kingdom Hays Full time

    Your New Company: Join this renowned biopharmaceutical organisation dedicated to developing innovative therapies that improve patients' lives. Leaders in the industry and looking for a biologics CMC Regulatory Affairs contractor on a 12-month assignment. Your New Role I am seeking a Regulatory Affairs Manager - CMC (Biologics) for a 6-month contract...

  • Regulatory Affairs Manager

    5 days ago

    Cambridge, Cambridgeshire, United Kingdom Hays Full time

    Your New Company: Join this renowned biopharmaceutical organisation dedicated to developing innovative therapies that improve patients' lives. Leaders in the industry and looking for a biologics CMC Regulatory Affairs contractor on a 12-month assignment. Your New Role I am seeking a Regulatory Affairs Manager - CMC (Biologics) for a 6-month contract for...

  • Associate Director

    4 days ago

    Cambridge, United Kingdom Gilead Sciences Full time

    Job Description At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s...

  • Associate Director

    3 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full time

    Associate Director - Regulatory Affairs page is loaded Associate Director - Regulatory Affairs Apply locations United Kingdom - Cambridge time type Full time posted on Posted 17 Days Ago job requisition id R0040532 For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. At Gilead, we’re creating...

  • Associate Director

    2 days ago

    Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full time

    Associate Director - Regulatory Affairs page is loaded Associate Director - Regulatory Affairs Apply locations United Kingdom - Cambridge time type Full time posted on Posted 17 Days Ago job requisition id R0040532 For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. At Gilead, we’re creating...

  • Quality Assurance and Regulatory Affairs Assistant

    4 days ago

    Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Full time

    Regulatory Affairs and Quality Assurance Assistant - Medical Devices - Cambridge Due to the growth of a medical devices company based in Cambridge, there is need for a new Regulatory Affairs and Quality Assurance Assistant to work with and support the company's Quality Assurance and Regulatory Affairs Manager. The team provide quality assurance and...

  • Regulatory Affairs Program Director M/F

    4 weeks ago

    Cambridge, United Kingdom ProductLife Group Full time

    Regulatory Affairs Program Director M/F - 080 Our RA teams are looking for a Program Director based in the UK to pilot and manage Regulatory Affairs outsourcing projects/programs for major clients for which specific dedicated programs and teams are put in place. About us Group 10 Missions You will act as a direct point of contact with...

  • Senior Manager/Director of Regulatory Affairs

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Hays Full time

    Join this renowned biopharmaceutical organisation dedicated to developing innovative therapies that improve patients' lives. Leaders in the industry and looking for a biologics CMC Regulatory Affairs contractor on a 12-month assignment. I am seeking a Regulatory Affairs Manager - CMC (Biologics) for a 6-month contract for my biotechnology client. You will...

  • Senior Manager/Director of Regulatory Affairs

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Hays Full time

    Join this renowned biopharmaceutical organisation dedicated to developing innovative therapies that improve patients' lives. Leaders in the industry and looking for a biologics CMC Regulatory Affairs contractor on a 12-month assignment. I am seeking a Regulatory Affairs Manager - CMC (Biologics) for a 6-month contract for my biotechnology client. You will...

  • Senior Manager, Regulatory Affairs

    3 weeks ago

    Cambridge, United Kingdom Relay Therapeutics Full time

    The Opportunity: We are looking for a strategic regulatory leader to join our growing regulatory team at Relay Tx. You will have the opportunity to ​help define and implement innovative regulatory strategies to expedite the development and approval of our transformative pipeline. You will serve as the regulatory representative on relevant project teams...

  • Senior Regulatory Affairs Manager CMC

    3 weeks ago

    Cambridge, United Kingdom Pharma Partners Recruitment Ltd Full time

    Job title: Senior Regulatory Affairs Manager CMC A growing Biotech in Cambridge with multiple Phase 3 assets are seeking a Senior Regulatory Affairs Manager CMC. The role will be responsible for the development, execution and tracking of regulatory CMC and medical device activities. Candidates must have protein experience in addition to medical device (auto...

  • Senior Regulatory Affairs Manager CMC

    3 weeks ago

    Cambridge, United Kingdom Pharma Partners Recruitment Ltd Full time

    Job title: Senior Regulatory Affairs Manager CMCA growing Biotech in Cambridge with multiple Phase 3 assets are seeking a Senior Regulatory Affairs Manager CMC. The role will be responsible for the development, execution and tracking of regulatory CMC and medical device activities. Candidates must have protein experience in addition to medical device (auto...