Senior Project Manager - Quality & Regulatory

Job Description

Life at Elvie - Meaningful work. Exceptional people

At Elvie, we don’t believe women's bodies are the problem. Instead, we believe the problem is that the needs of women’s bodies – and therefore, lives – have been ignored, misunderstood, and underestimated.

Founded by Tania Boler in 2013, Elvie has been improving women's lives through better – and smarter – technology ever since. We develop innovations that meet the unique needs and complexities of the female body so that women can take charge of their health across every life stage.

Our first product, Elvie Trainer, is a multi-award-winning device bringing hospital-grade pelvic floor care to the hands of women everywhere— it was even a gift in the Oscar Nominee Goody Bags! And now, we're proud to say that we're part of the NHS Supply Chain in the UK.

Our second innovation was Elvie Pump. Launched in 2019, it's the world's first silent, wearable breast pump, enabling women to pump wherever they please— even the catwalk at London Fashion Week. It’s since won numerous awards, including the Times 100 Best Inventions of 2019 and ‘Wearable Design of the Year’ at the Dezeen Awards. The initial success of our wellness tools gave us the means to expand our breastfeeding range to include Elvie Curve and Elvie Catch, both designed to give mothers total comfort and confidence.

As a business, Elvie has received more than 30 awards (including the prestigious Red Dot Design award). We’re ranked as one of the 15 startups ‘To Watch’ by The Sunday Times and Business Insider and ranked as the 13th fastest growing business in the UK by Syndicate Room. Our founder and CEO, Tania Boler, is regularly profiled in top-tier media titles, and, in 2021, Tania was named GLAMOUR’s Women of the Year: Technology Gamechanger.

In July 2021, Elvie announced an $80 million Series C funding, the number one position and biggest raise in an initial fundraising round in the femtech category.

What does it mean to work at Elvie?

You will be surrounded by people who want to improve everything and everyone around them. People who are passionate about our mission. People who are driven to solve tough problems and constantly consider the best ways to improve the health and wellbeing of women.

We're deeply proud of our values, which are intrinsic to the way we behave every day. We take them seriously because we want our culture to thrive:

• We make an impact - we are mission driven and not afraid to break boundaries. We relentlessly focus on going the extra mile to solve problems
• We are fearless innovators - we are passionate, curious and data-driven. We continuously embrace change and innovation
• We are in it together - we fail and learn fast, always as one team, and have fun along the way. We stay authentic and embrace our differences

About you

• You’re an accomplished Project Manager with a wealth of experience managing projects in commercial contexts
• You are competent in managing change projects, driven to improve systems, processes and, ideally, the continuous development of a Quality Management System to assure it is aligned with regulatory expectation, and achieve ISO 13485:2016 certification
• You have worked within organisations which are required to operate with robust quality standards i.e. within ISO9001 or similar standards
• Ideally, you’ve worked in Medical Device or Pharmaceutical sector, gaining experience with MDR, ISO 13485, FDA 21 CFR 820, and cGMP
• The idea of working within a successful scale up in a fast-paced role excites you

Please note: This is a 12 month FTC

Your Skills

• You've been through the time, spec and cost trenches and have emerged wiser and are able to put your lessons learned into practice
• You know your project management craft and can support it with judicious use of the right tools and processes to fit the projects and team as a whole
• You have excellent stakeholder management and communication skills, with the ability to create strong, trusted relationships at all levels of seniority
• You are familiar with the Agile manifesto, and adhere to its key principles including honest, open and transparent communication.
• You are able to estimate and monitor team resource requirements against the delivery of scope and time objectives
• You're an initiator. Rather than tell people what to do, you draw attention to actions that must be taken for the project goals to be met
• You’re hands on, you roll your sleeves up and get stuck in, you don’t expect others to do the work for you but you know when and how to collaborate with others to get things done
• You have experience of working without boundaries, and in fact thrive in environments where you can be instrumental in navigating through the ambiguity to deliver projects

What you’ll be doing

• This role is within the Project Management function, but you will be embedded into Elvie’s Quality and Regulatory team on a day to day basis and will operate as part of that team
• You will be the Project Manager responsible for managing Elvie’s ambition to achieve ISO13485 certification
• Set up fit-for-purpose governance for the project and team to keep on top of progress, reporting, risks and stakeholder management
• Provide a monthly status to the Executive Management Team, including budget reporting
• Facilitate workshops to identify process improvements
• Balance the elements of business as usual work with improvement initiatives required to achieve the compliance standards
• Provide overviews, or nuanced and detailed analysis of project progress to explain outcomes and facilitate decision making.
• Help develop ways of working for your team and the business, based upon the needs of the project and the people you are working with

Requirements

• Commercial experience as a project manager within quality, regulatory or compliance environments and have delivered change projects in these areas
• Experience of controlled and dependency based project management methodologies such as PRINCE2, and/or APM PMQ
• Experience with using tools to manage projects e.g. Jira, Pivotal Tracker, Asana, SmartSheet, MS Project
• Excellent problem solving, planning and prioritisation skills
• Experience of working with cross functional teams and understanding of the benefit of truly coordinated activities
• Experience of working with a range of stakeholders on a project, from the in-house teams (engineering, finance, sales, operations) to external contractors and senior management
• Excellent communication skills, both technical and non-technical with the ability to write reports, present, and discuss results

Benefits

Elvie is at the crest of a wave! Founded by women's health expert Tania Boler and tech entrepreneur Alex Asseily, Elvie is a collection of bright and motivated team members working across the business to shape the emerging femtech industry.

We are passionate about creating disruptive products that address the challenges that matter most to women and dismantling the taboos around women’s bodies. Here, you can be part of a business and brand that has a positive and meaningful impact on the world, while learning a great deal and having fun.

What are some of the perks of working at Elvie?

We are looking after you. As well as the chance to develop products with real work impact and working with dedicated and passionate colleagues, our benefits have flexibility and wellbeing in mind with

• Flexible work environment built on trust and autonomy
• Employee / friends & family discounts on Elvie products
• Annual personal development allowance & unlimited access to our learning & development platform
• A tax-efficient group pension scheme with SmartPension
• A tax-efficient charity donation scheme
• Life Insurance with Yulife
• Medical, Dental & Optical cash-plan
• Employee Assistance Program for you and your family
• Generous employee referral program
• Cycle Scheme & Tech Scheme
• YuLife Well-being app & access to SmartHealth app with unlimited GP appointments for you and your family, plus various well-being initiatives throughout the year

At Elvie, we believe in having diverse teams in which everyone can be their authentic self is key to our success. We encourage people from underrepresented backgrounds to apply and we don't discriminate based on race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, marital status, disability or age. We are a family-friendly employer with a culture based on trust, autonomy and flexibility, and are working on making our offices wheelchair friendly and breastfeeding friendly. We do our best to accommodate part-time requests and flexible requests as much as possible. We are also a member of UK Tech Talent Charter and proudly working in partnership with myGwork and Women's tech hub.