Manager/Sr. Manager- Regulatory & Clinical Affairs

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

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

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. Experience with multi category product portfolios (consumer electronics, childcare products, cosmetics, etc) is highly desirable. 

• →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 for medical devices, childcare products and consumer goods.
• →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 

• 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, MHRA, US FDA, FCC and Health Canada.
• Experience in product placement in MDSAP countries would be an advantage. 
• Ability to interpret worldwide 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. 

A member of our team will reach out to you after they have reviewed your application. You must ensure your application is completed correctly.

We do often receive a large number of applications for our roles, please don’t let visibility of this deter you from applying. We review and aim to respond to every application.

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.

This is an exciting 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 - having a sense of humour helps too 😉

At Elvie, we value building broad, diverse and inclusive teams - because we believe everyone being able to show up authentically at work 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 would like more information about the role (including salary) or need any support with your application please feel free to get in touch by email recruitment@elvie.com.