Quality Assurance and Regulatory Manager

Hertility is a women’s health company built by women, for women. We’re shaping the future of reproductive healthcare by pioneering unique diagnostic testing that provides data-driven and advanced insights into reproductive health, fertility decline and the onset of menopause. We provide expert advice, education and access to care - all from the comfort of your home.

31% of women will suffer from a reproductive health issue at some point and through our research, we aim to reduce the time to diagnosis through advanced at-home testing and specialist gynaecological care. We tailor pathways to the individual's reproductive goals, whether it be to explore their ovarian health and fertility options or overall hormonal health, such as confirming a PCOS diagnosis. Currently, we can screen for 18 of the most common pathologies which may lead to reduced fertility and signpost gynae cancers.

Ultimately, our aim is to change attitudes around reproductive health, both for individuals and in the workplace, and to encourage women to be proactive by tracking their reproductive health. We’re calling this the Reproductive Revolution!

The role

As the Quality Assurance and Regulatory Manager, you will report to the Head of Operations and be the Management Representative for the Quality Management System (QMS) and Information Security Management System (ISMS) within Hertility Health.

The ideal candidate will lead the regulatory activities of the business with a primary focus on maintaining the ISO13485 quality management system, the ISO27001 Information Security Management System, CQC registration, ensuring compliance of product development activities and supporting the regulatory activities required for CE-IVD marking of medical devices. Key responsibilities will include but not be limited to:

• Directing all aspects of Regulatory Affairs functions for medical devices, clinical governance and data protection.
• Being responsible for the generation of regulatory submission documents and preparation of technical file documentation / Compilation of technical files and regulatory submissions, / Compliance overview for design and development project.

• Serving as the company points person to interact with notified Bodies and/or MHRA.
• Serving as the company representative during quality and regulatory audits (internal and external), host customer and supplier audits,  regulatory inspections and participate in review of corrective action plans and effectiveness checks.
• Managing the company’s BSI portal.
• Developing and maintaining internal awareness and knowledge of regulatory standards, ensure compliance of the internal regulatory system, and provide suitable interpretation to the company.
• Being responsible for regulatory compliance (ref IVDR 2017/746).
• Promoting a culture of compliance to regulations, standards and procedures and risk management throughout the organisation / Promoting the awareness of regulatory and customer requirements throughout the organisation.
• Maintaining an awareness of new and proposed legislation that impacts the business and communicate/implement as required.
• Establishing, implementing and maintaining processes of the QMS and ISMS to ensure it is fit for purpose and reporting to management.
• Managing customer tracking as related to quality of products, complaints, and post-market surveillance.
• Developing and implementing programs for audits (internal, vendors) as well as the CAPA system.
• Setting and monitoring company quality and information security objectives.
• Defining regulatory requirements for external suppliers and supplier management.
• Presenting trend analysis results and regulatory metrics and insights to senior management.
• Having ownership and responsibility for CAPA, Complaints, Internal audits, training, document control, change management, supplier management.
• Ensuring compliance to ISO 13485:2016, ISO27001:2022 and ISO14971:2019 and relevant standards.
• Ensuring that equipment facilities and utilities are appropriately qualified and validated.
• Being responsible for health and safety.

Requirements

You’ll be a good fit if you have:

• Expertise in regulatory inspections and other formal audits for medical devices and/or cybersecurity. 
• Applicable experience in conducting internal audits, writing audit reports and analysing audits. 
• The ability to work independently while exercising good judgement and decision making within defined practices and policies.
• The ability to work cross-functionally.
• Excellent interpersonal, problem solving, risk analysis and negotiation skills.
• The ability to establish and maintain effective working relationships with co-workers, managers, and clients.
• Effective organisation, communication, and team orientation skills.
• Knowledge of the in vitro diagnostic industry including product development processes.
• Proficient in reading, analysing and interpreting scientific and technical information.
• Skills in MS Office packages (e.g. Excel, Word, Outlook, PowerPoint)

Benefits

We are a young, dynamic team working towards revolutionising women’s health. As a  Quality Assurance and Regulatory Manager, you will get a salary of between £45k - £60k + equity options as well as:

• 33 days paid holiday allowance (including public holidays).
• Company laptop.
• Flexible working hours - we trust that our team can manage their time and will get the job done.
• 5% pension scheme matched by 4% employee contribution.
• Mental health support from an in-house counsellor.
• Free access to Hertility Health products and services, including free of charge hormone and fertility tests and discount codes for employee friends and family.
• Opportunities for further learning and development.
• Enhanced Family Leave policy (maternity leave / paternity leave/ adoption leave).
• Progressive health leave (menstruation and menopause policies).

Equality & Diversity:

Hertility Health is an equal opportunity employer that is committed to diversity and inclusion both within the workplace and throughout our application process. We do not discriminate on the basis of race, religion, colour, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

We understand that applying for a new job takes a lot of work and we really value your time. We are really looking forward to reading your application.