We are seeking a highly skilled and motivated QA/RA Manager with a passion for medical devices. As a key member of our team, you will be responsible for ensuring compliance with quality assurance and regulatory affairs standards, as well as leveraging your communication skills to help build our brand & culture. This is a unique opportunity to combine your expertise in quality assurance and regulatory affairs with your passion for engaging content and marketing strategies.
Roles and responsibilities
- Develop and maintain our client’s quality management systems (QMS) and technical documentation in compliance with relevant regulatory requirements, including ISO standards and FDA regulation, MDR
- Stay up to date with the latest regulatory developments and industry standards to ensure ongoing compliance
- Be technically responsible of our UK RP service
- Anticipate any regulation tends and evolution to be able to best support our client in the wisest manner.
- Collaborate with the marketing team to create compelling content, including case studies
- Build a QARA internal structure to improve our responsiveness to our clients.
- Identify and attend relevant medical conferences, trade shows, and other industry events to network and promote products
- Providing leadership, guidance, and support to the team members, fostering a positive work environment and encouraging collaboration
- Ensuring effective communication and coordination within the team and with other departments or stakeholders
- Proven experience in quality assurance and regulatory affairs within the medical device industry.
- Strong understanding of quality management systems, regulatory requirements, and industry standards (e.g., ISO 13485, FDA regulations, MDR).
- On boarding new project, embracing challenging situation, handling unexpected questions is no hurdle for you.
- Excellent communication and presentation skills, with the ability to engage and influence diverse audiences.
- You look forward to a start-up mentality as a resourceful self-starter with a clear bias for action and results.
- Detail-oriented mindset with the ability to prioritize tasks and meet deadlines.
- Strong analytical and problem-solving skills.
- Self-motivated and able to work independently as well as collaboratively within cross-functional teams.
Why join us?
- Offices in London, and Paris & future offices in Switzerland & the USA with the opportunity for international development
- Yearly company-wide holiday & also workshops with the opportunity to work from the Paris office
- A flexible working environment in which we work hybrid from the trendy London Borough office (less than a 10-minute walk from London Bridge) and remote-based in which we will support with setting you up your home office
- A fast-growing start-up in the early stages of growth that gives you endless opportunities to grow rapidly with the business
- Endless opportunity for career development, no red tape or barriers for people who work hard to get where they want to be
- The people! A family feel working environment in which everyone wants to work hard, as well as be supportive and have fun
- 4-day working week: trial on going up to July 2023
- Generous Wellness & Fitness Allowance as well as a free office gym that can be used