Regulatory Affairs Manager

Elvie | London, United Kingdom
Flexible hours
Various work from home options
Dog friendly
Employment type
Full time

Elvie are looking for a Regulatory Affairs Manager to join their team.

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 Bolder 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.

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 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

What you’ll be doing in this 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.

Responsibilities:

  • 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

Location: Bristol or London, but we're flexible as long as you're happy to come into the office 2-3 days a week.

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 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

We're on an exceptional journey, and can offer you a truly purpose led career, with a culture built on trust, autonomy and flexibility. In addition, we'll give you:

  • Lots of flexibility – whether it’s working from home, doing the school run or life admin we understand that flexibility is essential and we trust you to do the right thing for you and us
  • Share options - we want everyone to have a stake in our success
  • An annual discretionary bonus scheme
  • 33 days annual leave (inc bank holidays), plus additional days to get married or move house
  • £100 contribution to your home working set up, to spend as you see fit
  • An annual personal development allowance of £150 & unlimited access to our learning & development platform, Learnably
  • Great parental leave policies, including paid emergency childcare
  • Healthcare plans, life insurance and an employee assistance programme for you and your family
  • A free Elvie trainer for you to keep or give away when you join
  • Generous employee / friends & family discounts on Elvie products
  • Wellbeing support from YuLife & access to SmartHealth app with unlimited GP appointments for you and your family, plus various well-being initiatives throughout the year
  • Lovely offices in great locations, with drinks and snacks provided, along with fun social events (when we're able to again!)

Belonging at Elvie

At Elvie, we believe having diverse teams in which everyone can be their authentic self is key to our success. We encourage people from all 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.

If you need any support with your application, please get in contact with us: elvie@jobs.workablemail.com or 0203 884 7223.

Elvie
Femtech
Scale-up
Tech for good
View company profile
Flexible hours
Various work from home options
Dog friendly