Website elvie Elvie

Two helping hands, to free yours

Description

Life at Elvie – Meaningful work. Exceptional people

We develop extraordinary and smart technologies designed to improve the lives of women. It’s a fascinating and challenging area that requires us to solve the problems that no one else has ever tackled before.

Our first product, Elvie Trainer, is an award-winning app-connected trainer that helps women strengthen their pelvic floor muscle via fun, five-minute workouts. It took the wellness industry by storm and is now available via the NHS Supply Chain. Our street cred is backed up by more than 12 awards for innovation and design, including the prestigious Red Dot Award and an IDA Design Award.

Our second innovation: Elvie Pump, the world’s first silent hands-free, wearable breast pump, has received international praise, including being listed as one of the Times 100 best inventions in 2019 and ‘Best of the Best’ at the Red Dot Awards 2020.

Our 3rd & 4th innovation: Elvie Catch and Elvie Curve launched on 7th October 2020. Elvie Curve uses natural suction to gently express milk during let-down while feeding or pumping from the other breast. It is small, compact, and securely worn in-bra. Elvie Catch, “Stops your leaks, not your day” is a set of two breast milk collection cups with slip-proof silicone skirts designed for total comfort and confidence. Discreet and fuss-free.

Elvie has received more than 30 awards, including being named one of 15 startups “To Watch” by The Sunday Times and ranked as the 6th fastest growing business in the UK by SyndicateRoom in 2019. Tania Boler has recently been rated as the 8th most influential person shaping British technology in 2019 by Business Insider and both products have been featured in the Oscar Nominee Gift Bags. In April 2019, Elvie announced a $42 million Series B, the largest ever fundraise in Femtech.

How do we like to work?

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’re fearless – We tackle taboos and break boundaries, requiring sensitivity and courage.
  • We’re innovators – We are passionate, curious and data-driven. We are constantly learning how to work smarter, faster and better. Always embracing change and innovation.
  • We’re in it together – Together, we are constantly learning, embracing change and seeking innovation, whilst having fun along the way. We stay authentic and embrace our differences.

About the role

Elvie has a need for a detail-oriented, passionate and dynamic individual with a desire to be an integral part of our growing Quality and Regulatory team. You respect rules and regulations but are not afraid to do things differently and challenge ‘business as usual’. You are able to understand and interpret global regulations to support the strategic placement of our growing portfolio of both medical and non-medical products into world-wide markets. Provide guidance to the cross-functional teams to successfully support and drive products to market, from R&D and Product Development, through to Sales and Marketing.

You are organised and logical and can form a clear path through the noise when complex decisions need to be made. You are able to work autonomously and be the authoritative voice for Regulatory Affairs. You can develop plans of action and communicate them with confidence to all functions and levels within the business.

You will have experience working within the Medical Device industry, in a global regulatory focused role. You are excited by the prospect of defining the regulatory strategy and best practices in a rapidly growing and exciting business.

What you’ll be doing

  • Partner with cross functional teams to develop global regulatory requirements and timelines that align with the business expansion and new product launches.
  • Provide clear and unambiguous guidance on regulatory requirements for new market entry and design changes.
  • Lead regulatory submissions to support new product launches including the development and maintenance of FDA 510(k)’s, Technical Files and Essential Requirements Checklists.
  • Communicate with world-wide agencies, in-country representatives and regulatory bodies to support our products.
  • Understand new or changing regulatory landscapes that could impact our products.
  • Support the development and continual improvement of internal regulatory processes

Requirements

  • A degree in a relevant engineering, design or science discipline (or equivalent qualification).
  • Extensive experience in medical device regulatory affairs including direct experience working with EU Notified Bodies, EU Authorised Representatives, FDA and Health Canada.
  • Experience in product placement in Japan and China would be an advantage.
  • Ability to interpret WW regulations to ensure uninterrupted supply of our products to our customers.
  • Experience ensuring a high level of compliance with MDD 93/42/EEC Medical Devices Directive, MDR, ISO 13485, 21 CFR 820.
  • Must be familiar with commonly used productivity & statistical software such as Microsoft Office, Google suite and eQMS solutions.

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.

To apply for this job please visit apply.workable.com.