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.
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: Permenant
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