Regulatory Affairs and Quality Assurance Specialist

Job Description:

(COMPANY NAME) is a MedTech scale-up in a fast-growing medical field. We are looking for new talent to join our team!

🦷 What are the value added of (COMPANY NAME)'s solutions for its clients 🦷

✦ Our SAAS monitors and optimizes orthodontic treatment for doctors and patients alike using our app and patient platform
✦ (COMPANY NAME) brings the first AI-driven technology in the oral healthcare space
✦ With more than 200 filed patents on our technology, we are leading an entire industry in how we approach the orthodontic experience
✦ Our handy tool, the Scanbox™, helps patients and doctors to easily detect intra oral observation
✦ Their patients smile again 😁

(COMPANY NAME) was promoted in the Next40 for the second year in a row.

💼 The RA/QA Specialist Role 💼

✦Participates in communication inside and outside the company to educate your (COMPANY NAME) colleagues and clients regarding quality & regulatory requests.
✦Ensures that the quality system is maintained or updated in compliance with ISO 13485 and ISO 27001 and other future applicable quality (MDSAP) or regulatory requirements.
✦Leads the use in the company of a quality system software to improve traceability, maintenance and avoid wasting time by an automatization of low added value actions
✦Reviews corporate quality KPI and prepare quality management reviews, including Oversight of key quality processes, including Internal/External audit, Supplier Quality, CAPA,
✦Post-Market Surveillance (Complaints, Holds, Field Action), Change Control, Data & Documentation Management, Training and Product Release.
✦Defines the regulatory strategies in an unclear, still moving innovative field: healthcare specific software and mobile applications. This includes a close collaboration with marketing, R&D and clinical departments to explain regulatory requirements.
✦Prepares and follows-up medical device registration applications for the targeted markets (registration applications, amendments...), such as CE countries, Australia, US, and others
✦Maintains registrations after the product is placed on the market.
✦Ensures communication with competent authorities.
✦Defines the labelling and check promotional material
✦Ensures the needed regulatory & quality assurance watch

✅ You will be successful in this role if you have ✅

✦Engineering Degree or Pharmacist or MsC in Regulatory Affairs or Medical/Scientific field.
✦Experience in a med-tech company or similar life-sciences organization (internship or 1 to 3 years)
✦Good knowledge or experience in the regulatory framework applying to medical devices, including EU & USA:
* MDR 2017/745, including GSPR, technical file, PMS, PMCF and clinical evaluation requirements
* 21 CFR Subchapter H, including labelling and device requirements, premarket submissions, quality system regulation
* ISO 14971, risk management of medical devices
* IEC 62304, knowledge in software development
✦Ability to communicate effectively and build relationships with internal/external stakeholders.
✦Excellent organisation, rigour and analytical skills
✦Proficient in oral and written English

💯 It would be fantastic if you have 💯

✦Experience in a startup or scale-up environment
✦Knowledge in international regulation other than CE & USA regarding medical devices such as MDSAP
✦Other languages than French and English
✦Experience in the dental area

🌎 Our work environment 🌎

At (COMPANY NAME) our employees thrive because :

✦ We are collaborators! It is a core value and our team of researchers, doctors, developers, salespeople and all of our stakeholders work together to put our customers first!
✦ (COMPANY NAME) is a diverse, multicultural company: you can find more than 20 nationalities throughout our teams

🤝🏼 What we bring to our employees 🤝🏼

✦ Your ideas will be heard! Our culture promotes initiatives, ownership and feedback
✦ Everyone is committed to supporting your professional development because we understand that no one can know everything
✦ We place significant importance on the quality of work-life balance
✦Here are some perks that we offer our employees:

Mutuel Alan
Swile card
Free shares plan
Hybrid work
Flexible personal time off policy
Gymlib
Corporate events
Referral policy

This role is Paris office based.

(COMPANY NAME) is an equal opportunity employer and offers an intercultural and inclusive workplace. The diversity of our teams is one of our strengths. We work every day with more than 30 nationalities in different countries all over the world. We welcome and encourage applications from people with disabilities. For those people we are committed to providing appropriate accommodation.

The above is not an exhaustive list of all duties, responsibilities and qualifications associated with the job. Other duties may be assigned