Product and Service Governance Lead
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.
To be considered for the the role you will require the following:
Essential Criteria;
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.
Within this position, you will mainly be;
* 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.
Our Commitment to you
We are committed to building a diverse team of HBSUK who are smart, nice, and get things done where everyone at HBSUK is empowered to bring their authentic self to their work. We are all responsible for stewarding a high-performance culture in which all HBSUK employee's belong and thrive. We are proud to be an equal opportunity employer and welcome applications from people of all backgrounds and experiences.
If this opportunity is something which appeals to you, get in touch today, so we can ensure you have the best experience throughout your search.