Regulatory and Quality Affairs Manager H/FSalarié CDI
MI SAM Recherche pour l'un de ses clients en Principauté de Monaco un(e) Responsable Affaires règlementaire et Qualité.
As Regulatory and Quality Manager, you will:
- Provide scientific support to lead the development of regulatory strategies and interaction with global Health Authorities;
- Help with planning, preparing and reviewing regulatory documentation to ensure its suitability for submission to health authorities.
- Prepare and submit regulatory submissions to notified bodies as required for global approvals for technical dossiers related to MDR.
- Define, implement and organize action plans to ensure the quality of the company's products and services.
- Ensure of the quality system stages of development, make sure of the quality of the providers and suppliers and their regulatory compliance.
- Perform audit (internal and external): ISO 13485.
- Provide strategic input and regulatory advice to the project teams.
- Be responsible for the filling of the documentation relating to medical device vigilance and will be the privileged speaker of the National Safety Agency and other regulatory authoritiesrelated to the company’s activity.
- Work on the creation and updating of the regulatory developments and quality assurance processes.
- Maintain close contacts and ties with the Certification Agency and Suppliers.
- Ensure regulatory watch and horizon scanning of European Community regulations (e.g. EU regulation 2017/745) and for the consolidation of regional and local assessments to issue regional overviews and to propose action plans.
- Review and approve new packaging based on supplier’s documentation (compliance certificates, declaration of conformity, mandatory information…). Provide a support on packaging regulatory compliance and packaging claims.
- Participate to transversal and long-term innovation projects to ensure packaging regulatory compliance, support risk tracker development for packaging regulatory topics. Manage external consultants on technically special regulatory issues with a focus on output and risk mitigation deliverables.
- Contribute to cross-functional projects in partnership with internal stakeholders (R&D, Marketing, Procurement, Legal, Finance, Business).
- Stay up-to-date with EU and Non-EU regulatory requirements and guidelines.
- Support with cosmetic products creation and follow-up from a regulatory and compliance perspective.
- Manage and maintain continuous improvements within the R&D department.
- Create and deliver training programs and development activities that are in align with regulatory guidelines.
- Provide leadership with the planning and execution of projects within the R&D department.
- Assess changes to products.
- Bachelor’s degree or Master’s or PhD degree in biological sciences, biotechnology, pharmacology, chemistry.
- Good working knowledge of the MDD/MDR, ISO standards. Previous work experience in the pharma or medical field/ medical device field.
- At least 5+ Years Experience with regulatory affairs.
- Equivalent experience across Medical Device regulations and relevant biopharmaceutical development experience (e.g. Pharmaceutical Development, Analytical Development, Process Development, Quality Assurance, or Quality Control) will be considered.
- Speaks English Fluently (B2). Italian is an asset.
- Excellent writing and speaking skills, and ability to deliver reports and minutes.
- Proficient with Microsoft Office.
- Project Management skills. Ready to embrace a culture of flexibility and innovation, patient centric with a very high degree of urgency.
- People skills.
- Known as a respectful, supportive and solution-oriented team player, with highly effective organizational and planning skills to apply daily in a multidisciplinary and matrixed environment.
- Character: Systematic, Logical, Ethical, Direct, Independent, Outgoing, Curious, Challenging.
- Fluent in English, Italian, French, and other languages.
- Experience with ophthalmology medical device and/or pharma related to ophthalmology.
- International experience: FDA, IVD regulations and other international regulations.
· Travel: This job may require domestic and International travel(around 20% of the time).
· Physical Demands: This job requires no extraordinary physical demands. Examples: standing, walking, lifting/moving objects < 25 pounds, vision req., noise level, etc. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Si vous êtes intéressé par cette opportunité, veuillez nous adresser votre CV en Français et en anglais.