Head Of Regulatory and Quality Affairs

Entreprise

« Be yourself, everyone else is already taken. »

For over 20 years, PERSUADERS RH has built its expertise in recruiting complex profiles and has developed a true legitimacy in supporting executives and COMEX members, coaching, transition management and HR consulting. We claim our difference by working beyond skills…on the aptitude and personality of the profiles we support.We are intimately convinced that human qualities are the pillars of your success.

The company, an award-winning startup with R&D in Toulouse and San Francisco, is a pioneer in the development of non-invasive breath analysis solutions for the screening, monitoring and detection of different biomarkers in exhaled breath.The company is developing its first product, a miniaturized breath analyzer for monitoring glucose concentration in pre-diabetics and type 2 diabetics. The device detects the type and concentration of volatile organic compounds in breath. The solution is pain-free, gentle, affordable, and produces significantly less waste than existing finger stick blood glucose or continuous glucose monitors.

To support its growth, the company is seeking its future Head of Regulatory Affairs and Quality (M/F).

Poste

Main Responsibilities

Lead and oversee all regulatory and quality activities for the company’s products and services
Ensure the company’s compliance with national and international regulations applicable to medical devices
Develop and implement a robust quality management system compliant with ISO 13485 standards, other medical device ISO standards and good manufacturing practices
Implement and supervise an effective risk management process
Manage regulatory submission processes, obtaining authorizations, and product certification with relevant authorities
Supervise internal and external audits related to quality and regulatory compliance
Train and raise awareness among staff about regulatory requirements and quality practices
Represent the company to regulatory bodies and professional associations

LOCATION

The position requires spending a significant amount of time in Toulouse, where the laboratory is located. Working from home is partially possible.

TRAVEL

The position entails regular travel within the country and overseas to meet with authorities, vendors, and other stakeholders.

COMPENSATION

For a qualified individual who meets these specifications, the Company is prepared to offer a competitive compensation package.This key position at the company requires solid expertise in medical device regulation and quality, as well as the ability to effectively manage regulatory processes and ensure company compliance.

Profil

Required Qualifications and Experience

Advanced degree in engineering, life sciences, or a related field
Minimum of 5 years of experience in a regulatory and quality role for medical devices
Excellent knowledge of regulations applicable to in vitro-diagnostics and medical devices (FDA, CE, etc.)
Proficiency in ISO 13485, ISO 14971, IEC 62304, HITRUST (including SOC2, NIST, ISO 2701 standards), and good manufacturing practices
Proven experience in implementing and managing quality management systems
In depth familiarity with the risk management process according to ISO 14971
Strong project management and problem-solving skills
Hands on mentality
Excellent written and verbal communication skills in French and English