Les 74 meilleures offres d'emploi : en tant que Ingénierie, , à Massy (avril 2026)

Regulatory & Quality Affairs Engineer

il y a 4 jours

Clamart

Our mission is to strive to create high-tech implantable devices and diagnostic solutions for cardiac diseases, which are accessible to the greatest number of people, while offering valuable services to patients, physicians, hospitals and health care insurers. As for us the patient always comes first, we strive daily to deliver medical devices for heart related conditions that help people live longer and healthier lives. Within the Regulatory and Quality Affairs NPI (New Product Introduction) team based in Clamart (92), you will join a team of 3 people and report to the Regulatory and Quality Affairs Manager. Your missions will be as follows : Regulatory Affairs As a stakeholder in the project teams, you will implement the functional activities of regulatory affairs to support product development, clinical activities, manufacturing, marketing and other quality system activities. As such : • Participate on project teams to provide input to ensure that appropriate regulatory requirements for market clearance or clinical trials are built into project plans, • Summarize technical documents for regulatory submissions, • Develop regulatory submission applications to introduce new or modified devices, new or expanded indications for use or changes to the manufacturing/quality processes into the marketplace. Maintain regulatory files to ensure the company's compliance with regulatory requirements, • Participate in meetings with regulatory officials for purposes related to market approval, • Provide senior management practical operations-oriented interpretation of regulatory requirements governing medical devices, • Respond to registration requests from regulatory authorities, • Review advertising and promotional literature, quality system documentation such as Clinical and Regulatory strategic plans, procedures, verification and validation protocols and reports, investigation (e.g., complaint or CAPA) and clinical protocols and study reports, • Implement initiatives to enhance efficiencies, productivity, and quality that are consistent with company changes and growth without adversely impacting quality or regulatory compliance, • Collaborate with Clinical Affairs, Product Development, Quality, Marketing and Operations to drive best practices into project and fulfill design control activities and other Product Development Projects deliverables in a timely manner, • Ensure local regulatory requirements are met prior to distribution Quality Engineering During product development, you will also be responsible for Quality Engineering activities : • Develop, review and approve quality system documentation such as procedures, validations, experimental design studies and validation reports, • Ensure that design control, design transfer and process validation activities conform to internal and regulated requirements, • Ensure complete traceability of design inputs to design outputs to V&V activities, • Maintain the Risk Management file (risk management plan/report, FMEA, assessment of risk associated with design/process changes, risk control measures, Risk Benefit Analysis), • Provide input to manufacturing process development and validation plan, • Develop and maintain effective relationships with internal personnel and external stakeholders to facilitate and drive the resolution of regulatory compliance and product quality issues, • Assess product changes and define required activities, • Approve deviations and Change Requests, • Drive root cause analysis investigations, HHE and corrective actions in a timely and compliant manner, • Identify which trends or events warrant investigation via the CAPA process and initiate CAPA investigations as required by the local procedure, • Assist with internal/external quality audits Your profile • Education: MSc in Industrial Quality, Electrical, Mechanical, Software or Biomedical Engineering (preferred)., • 5 or more years of experience in a regulated environment industry such as a FDA Class 2 or 3 (or equivalent international classification) medical device manufacturer., • Strong interpersonal skills. Good team player. Ability to work in cross-functional teams in the development of new products or changes related to current products, • Knowledgeable about worldwide clinical and regulatory environments we compete in,, • Pragmatic and result-oriented. Project oriented mindset and excellent problem-solving skills, • Analytical mind and quick understanding, • Strong written and verbal communication skills in English as you will be working in an international environment, French a plus, • Proficient in MS Office including Word, Power Point, and Excel., • ISO13485, EU MDR 2017/745, ISO14971, 21 CFR 820, • Knowledge of Statistical Process Control What we offer Of course, there are compensation, various benefits, career opportunities and the whole package you usually find in a company. What really matters in the end is why we come to work every day and that what we do really makes a difference. Unlike similar positions in larger companies, you will get the unique opportunity to work in a human scale yet international organization and support life-saving products all over the world. Each of us at MicroPort CardioFlow is here to help people live longer and healthier lives no matter which is our expertise.

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