HBSUK
Product and Service Governance Lead
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ABOUT THE ROLE
The Product & Service Governance Lead is a critical role responsible for establishing, maintaining, and evolving our product and service governance framework. This individual will ensure continuous compliance with MHRA Class II medical device standards and other relevant regulations, minimising risk and enabling the continuous enhancement of our offerings. This role is pivotal in safeguarding product integrity and promoting a user-centric approach across all product lifecycles, collaborating with various internal and external stakeholders.
MAIN RESPONSIBILITIES
- Product and Service Governance Oversight: Own the continuous implementation and adherence to all product governance processes. This includes maintaining and evolving our comprehensive Standard Operating Procedures (SOPs) to align with evolving regulatory requirements and best practices, including all cybersecurity and usability studies.
- Regulatory Compliance & Risk Management: Champion MHRA and relevant regulatory compliance, integrating updates into our product and service lifecycle. Lead product risk review meetings (with representation from operations, clinical, and product), ensuring all risk registers are current at each release point and maintaining the product and class 2 medical device technical file. Audit the effectiveness of controls and mitigations, ensuring they are safe, effective, timely, and meet regulation.
- Release Management & Documentation: Oversee the release sign-off process, ensuring all necessary documentation for Class II medical device registration is meticulously prepared and maintained for every product iteration. This includes verifying contributions from all team members to ensure compliance.
- Feedback & Continuous Improvement: Drive product and service enhancement by owning the accumulation of feedback across the business and running monthly review meetings to action insights, ensuring these insights feed back into governance processes.
- Governance Representation: Serve as the primary product representative at key governance forums, including Clinical Governance, quarterly reviews, and complaints meetings, risk meetings, ensuring product integrity and a user-centric approach are maintained.
- Cross-functional Governance Collaboration: Collaborate closely with the Director of Product & Services, Product Manager, and other relevant stakeholders to ensure seamless integration of governance processes across product strategy.
- Data Privacy: Liaise with the Data Protection Officer to ensure data privacy is always considered in design.
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FLEXIBILITY
This job profile is not intended to be exhaustive, and it is likely that duties may be altered from time to time in the light of changing circumstances, in discussion with the post holder. This role profile is intended to provide a broad outline of the main responsibilities only.
EDUCATION QUALIFICATIONS & TRAINING
- Educated to degree level or equivalent in a relevant field (e.g., Quality Management, Regulatory Affairs, Product Management).
- Experience with quality management systems (e.g., ISO 13485).
EXPERIENCE
- Proven experience in product governance, regulatory affairs, or quality assurance within the healthcare technology or medical device industry (Class II medical device experience highly preferred).
- Strong understanding of MHRA, GDPR, and other relevant healthcare regulations.
- Experience in managing risk registers and leading risk review meetings.
- Demonstrated ability to manage documentation for regulatory submissions and product releases.
- Experience in driving continuous improvement processes.
- Knowledge of Privacy by Design principles.
- Excellent communication and stakeholder management skills.
KNOWLEDGE AND SKILLS
- In-depth knowledge of product lifecycle management within a regulated environment.
- Strong analytical and problem-solving skills.
- Ability to interpret and apply complex regulatory guidelines.
- Exceptional organizational skills and attention to detail.
- Proficiency in documentation management systems.
- Ability to collaborate effectively with cross-functional teams.
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Additional Information
- Start Date: ASAP
- Who will the person report to? And will they have any direct reports?
- Reports to: Head of Change & Strategy
- Direct Reports: No direct reports.
What are the most important behavioural competencies the ideal candidate would demonstrate?
- Attention to Detail: Exceptional organisational skills and meticulousness are critical.
- Analytical Skills: Ability to interpret and apply complex regulatory guidelines.
- Stakeholder Management: Excellent communication skills to collaborate effectively and influence cross-functional teams.
- Problem-Solving: Strong analytical and problem-solving capabilities.
How does this role fit within the team and the wider department? Who are the key stakeholders they will interact with?
- Fit: This is a critical role within the product and services function, acting as the central point for all governance, risk, and compliance matters related to our offerings.
- Key Stakeholders: Product Managers, Clinical team, Operations team, Data Protection Officer, and representatives at key governance forums (e.g., Clinical Governance).
EQUALITY AND DIVERSITY STATEMENT
We are dedicated to promoting equality of opportunity for all employees and job applicants. In line with the Equality Act 2010, we strive to create and maintain a working environment in which everyone is able to make the best use of their skills, free from discrimination or harassment, and in which all choices are based on merit. No person is subjected to any less favourable treatment on any discriminatory grounds on the basis of age, disability, gender reassignment, marital or civil partner status, pregnancy and maternity, race, colour, nationality, ethnic or national origin, religion or belief, sex or sexual orientation.
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