[Hiring] Manager/Sr. Manager- Regulatory & Clinical Affairs @Elvie

Role Description

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.

Qualifications

• 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.

Requirements

• 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.

Benefits

• 9-day fortnight working pattern - 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 believe trust and flexibility allows everyone to show up as their best selves.
• 25 days’ annual leave, plus bank holidays.
• 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.
• Generous parental leave policies; maternity & adoption (16 weeks at full pay, then 8 weeks paid at 75% followed by 15 weeks at SMP rate), paternity/partner (6 weeks at full pay to take at any point during the first year of your child’s life), shared parental leave.
• 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.
• 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.