Complaint & Post Market Surveillance Manager, UK

London, England, United Kingdom (Hybrid)       ·       Full time / Permanent

About the job

Giving the world more time.

For the first time in human history we have the technology, data, and insights to redefine health. Together with our partners, we will make the leap from reactive to proactive medicine. By collectively benefiting from the data we individually generate, we can all live our longest, fullest lives. Huma partners with scientists, technologists, healthcare, and life sciences professionals to understand, treat, and ultimately prevent ill health. Giving knowledge and power to those with medical conditions, while saving clinicians time, energy, and valuable resources.

Your mission

• Ensure that the organisation’s complaint handling, vigilance & recall processes comply with the applicable regulations and standards (e.g ISO 13485, MDR 2017/745, 21 CFR Part 820, MDSAP)
• Ensure that the complaint handling, Post Market Surveillance, Vigilance & Recall processes are audit ready at all times
• Review all received complaints as per the organisation processes
• Prepare and conduct training sessions (including training materials)
• Identify and implement continuous improvement through the training process
• Work with different teams across the whole organisation on CAPAs, NC’s
• Report KPIs on a regular basis
• Support the customer success team by reviewing complaints from a QARA perspective

From day one in this role, we’ll expect you to have

• Good working knowledge of ISO 13485, 21 CFR Part 820, MDR 2017/745, ISO 14971
• Experience with Medical Devices
• Ability to manage multiple projects at once
• Evidence of team working skills and flexibility
• Attention to details is a must

It’s Great, But Not Required, If You Have

• Academic background in healthcare, medical device or pharmaceutical
• Experience in Good Clinical Practice
• Experience of Software as a Medical Device

You will thrive at Huma if you are

• Resilient – show adaptability, be a pro-juggler and have the ability to move fast
• A strong communicator – you practice open and clear dialogue, while listening with fairness
• Detail oriented – working with people’s health means we obsess over every detail and make sure we get it right
• A problem-solver – a passion to creatively find solutions that solve one of the biggest global challenges – human longevity
• An Industry Expert – well networked, you used your knowledge and contacts to teach best practices
• A collaborator – you achieve some of the greatest results by working together

What We Can Offer You

• Competitive pension scheme & salary sacrifice with Aviva
• Prioritisation of your health and wellbeing with ClassPass or Urban Sports Club
• EAP scheme and gym membership discount with AXA
• Progressive private health insurance with AXA Health
• AIG Life & income protection scheme
• Generous share options – every employee is an owner
• 25 days paid vacation + UK bank holidays
• Home office allowance to support home working
• Bike2Work scheme
• Season ticket loan
• Family first culture – giving the flexibility you need
• Growth & development opportunities

Come join us!

We believe magic happens when you bring together diverse ideas, experiences, and styles. We want to create a world where people live longer, fuller lives, and to do that well we need a team that represents all of the people and communities who use our solutions. We aspire to create an environment where everyone has the opportunity to do their best work. We are always looking for ways to improve so if you have any suggestions, please get in touch.

Dear recruitment agency friends: Huma attracts an amazing number of direct candidates and we do not need any help at this stage, so please do not send us unsolicited agency resumes. This is not a great use of your time, and we will not accept any liability or fees for any resumes or candidates which we have not asked you to find for us.

Please click here to apply.