Regulatory Affairs Specialist

The position: Regulatory Affairs Specialist

Life at Elvie; Meaningful work, Exceptional People

We're Elvie. We create smart products, new solutions, and a fair few taboo-busting conversations while we’re at it. Founded by Tania Boler in 2013, we develop extraordinary innovations designed to improve women’s lives. It's a fascinating and challenging area that requires us to solve problems that no one else has ever tackled before.

At Elvie, you’ll 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 problems and constantly consider the best ways to improve the health and wellbeing of women.

Find out more about life at Elvie here.

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’re mission-driven and not afraid to break boundaries. We relentlessly focus on going the extra mile to solve problems.
• We’re fearless innovators: We are passionate, curious, and data-driven. We continuously embrace change and innovation.
• We’re 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.

Did you know?

In some regions our amazing products are considered to be medical devices. This means we maintain our Medical Device quality management system in compliance with ISO 13485:2016, to support the development of our groundbreaking products.

About the role:

Okay, we’ve waffled long enough. So let’s get to the good bit: You.

As a Regulatory Affairs Specialist, your role sits within the Quality and Regulatory team, reporting to the Lead Regulatory Affairs Manager.

You shall be a confident individual with the ability to communicate across all levels of the organisation and work well in a fast-paced environment. You respect rules and regulations but are not afraid to do things differently and challenge ‘business as usual’. 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 an authoritative voice for Regulatory Affairs. You can execute plans of action and communicate them with confidence across 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 supporting the regulatory strategy and best practices in a rapidly growing and exciting business.

Location: Hybrid working; a mix of working from our Bristol office & working remotely

Employment type: Permanent

What you’ll be doing at Elvie:

• Support cross-functional teams to develop global regulatory requirements and timelines for business expansions and new product launches.
• Provide clear and unambiguous guidance on regulatory requirements for new market entry and design changes.
• Support regulatory submissions for 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 Lead Regulatory Affairs Manager with the development and continual improvement of internal regulatory processes

Requirements

What we are looking for:

• A degree in a relevant engineering, design or science discipline (or equivalent qualification).
• Experience in medical device and/or consumer electronics regulatory affairs including direct experience working with EU Notified Bodies, EU Authorised Representatives, FDA and Health Canada.
• Experience ensuring a high level of compliance with MDR, ISO 13485, 21 CFR 820.
• Must be familiar with commonly used productivity software such as Microsoft Office, Google suite, Slack, Asana and eQMS solutions.

Benefits

The benefits you’ll get:

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

• 9 Day Fortnight - for our full time employees we work 9 days every fortnight with every other Friday as a non-working day for you to spend as you wish!
• 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
• 25 days’ annual leave, plus bank holidays
• 8 extra life leave days; getting married, moving house, menopause or just things that you can’t put a label on that matter to you
• 5=10 leave: 10 days’ additional leave on your 5th and 10th years of service!
• £100 contribution to your home working set up to spend as you see fit
• An annual personal development allowance of £200 and unlimited access to our learning and development platform, Learnerbly
• Generous parental leave policies; maternity, paternity/partner, shared & adoption
• Healthcare plans, life insurance, and an employee assistance program for you and your family
• A tax-efficient group pension scheme
• Group income protection; protect your salary if you get sick
• A free Elvie trainer for you to keep or give away when you join
• Generous employee and friends & family discounts on Elvie products
• Wellbeing support from YuLife and 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

What you can expect after you’ve applied:

A member of our recruitment team will reach out to you after they have reviewed your application. You must ensure your application is completed correctly, and we strongly encourage you to add a cover letter or note to let us know why Elvie’s the right fit for you.

We would like to get to know you through your background, attitude, experience and understand your motivation to work with us. Our interview process varies depending on the position, but it typically looks like this:

• 20-minute video call with one of our recruiters
• 30-45 minute video call with the hiring manager
• 45-60 minute video interview (some positions may require you to complete a task/presentation)
• For some positions, there may be an additional interview with one of our senior leadership team

This is undoubtedly a great time to join Elvie. You’ll have a voice, make an impact, and have the opportunity to mould your role. So be ready to learn, have fun, and be inspired by our passionate, talented team — and having a sense of humour helps too. 😉

We can’t wait to hear from you!

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: [email protected] or 0203 884 7223.