Regulatory Affairs / Quality Specialist Medical Device
About BIORIUS
Established in 2008, the group BIORIUS is mainly active in the cosmetic industry and is reputed for its fine scientific and regulatory affairs services. Among other missions, BIORIUS helps brands to comply with the legal requirements of various regions/countries and facilitate the placing on the market of their products. Operating on a global scale, BIORIUS is leader in EU-related compliance services and offers an effective turnkey solution to companies targeting this market. Today, BIORIUS works with hundreds of cosmetic companies, including many larger corporations and iconic brands. More details are available at www.biorius.com.
About the Position
Historically focused on human health, BIORIUS is adapting to the new constraints and opportunities suggested by its market. The Medical Device business unit recruits a Regulatory Affairs / Quality Specialist. Since many developments are expected and capacity building is needed, this position requires a senior profile, who will be able to work effectively with a high level of autonomy and dedication. The Regulatory Affairs / Quality Specialist would report either to the Medical Device business unit manager.
This function requires a very good sense of organization, great flexibility, excellent oral and written communication skills, and a true taste for perfectionism. The ideal Regulatory Affairs / Quality Specialist has a scientifically-sound profile, a meaningful professional experience, and a business mindset.
The primary responsibilities of the Regulatory Affairs / Quality Specialist are:
- Strong technical knowledge and communication skills with the ability to effectively engage both internal and external stakeholders on medical device regulatory and quality issues and team building.
- Evaluate existing gaps in customer’s documentation and QMS to obtain or keep CE marking.
- Understand (EU) 2017/745 requirements for purposes of device regulatory compliance and registration. Global understanding of (EU) 2017/746, FDA, MDSAP is a plus.
- Writing of Technical Documentation and QMS implementation.
- Assume the role of Person Responsible for Regulatory Compliance.
- Practice of internal or suppliers’ audit; certification is a plus.
About the Successful Candidate
- A minimum of a Master’s degree, engineer in health or sciences is required; Regulatory, Quality and/or Clinical specialization is a plus.
- Minimum of 4-5 years of experience practicing RA/QA with Medical Devices is required.
- Experience with high risk classified devices.
About the Salary Package
- A competitive salary and an extra-legal package in line with country practices.