We've got a great role for a Regulatory Affairs Manager to work on a market leading technology supporting patient centred clinical trials. While others rely on aggregated data which blocks subject re-engagement, my client can rapidly reach back to contact patients for clinical studies, engage in data collection from home, and to collect biomarker and genomics samples.

Key Skills

Will have 3-5 years experience and a deep understanding of the evolving Governance and Regulatory landscape for digital health technologies, the life science sector and challenges facing health tech SMEs and their quest for globalisation. In addition, knowledge and experience working with healthcare organisations, contract research organisations and pharma to understand their needs. This role will report directly to the VP of Product and Compliance.

Key Responsibilities

• Develop and implement a quality and regulatory strategy for the UK, EU and North America.
• Keep abreast of regulatory developments within or outside of the company as well as evolving best practices in governance.
• Ensure that effective systems and controls are in place to meet regulatory, legislative and corporate governance requirements
• Work collaboratively with the leadership team to address any governance or regulatory deficiencies or risks
• Lead the development, management and review of SOPs and other Quality Management Documents
• Support the team in embedding good regulatory and governance processes into practice and manage any company training programs required
• As required, monitor any new standards, risks or changes in legislation that may impact the company.
• Work with the sales and business development teams to manage new and existing Sponsor and Healthcare Organization relationships - specifically understanding their governance and regulatory requirements, ensuring their needs are met.
• Act as point person on any external audits including those with Sponsors, Healthcare Organizations and any regulatory agencies
• Act as lead in the development of compliance requirements to support HIPAA, ISO 27001, SOC 2 and GDPR certifications
• Select and manage any tools required to support regulatory compliance

Core Skills

• Self-motivated and ability to prioritize busy workload in a fast-paced environment
• Have an intimate understanding of the regulatory and governance challenges faced health tech SMEs
• Have sound knowledge of the relevant regulations, standards and requirements (e.g. MDR, ISO 27001/9001/13485, HIPAA, GDPR, Cyber essentials plus, DSP toolkit)
• Have practical experience managing and maintaining ISO compliant products with strong operational governance processes.
• Have knowledge and experience with global (country/local) regulatory and legal requirements related
• Be passionate about our mission to support better execution of clinical trials

Company Culture

No matter what an organisation is trying to achieve, success or failure is inextricably linked to the people within it. For a young company, there is no redundancy so this relationship is turned up to eleven.

We punch well above our weight due to the quality of the team we have built, and their dedication to our shared vision. Recognising this dedication we have a fantastic benefits package and accompanying culture. This includes:

• A meaningful share options package so that you own a part of the company and get rewarded for all of your hard work
• 28 days holiday (including bank holidays)
• Remote first work environment
• Job Type: Full-time Competitive Salary

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