Manager, Regulatory Affairs – Medical Devices

Maroc

Publié il y a moins de 7 jours

Décryptage du poste par Postule AI

Résumé du rôle

Seeking an experienced Manager of Regulatory Affairs to lead Cook Medical's regulatory function. Supervise team operations, ensure compliance with global medical device regulations (ISO13485, EU MDR, FDA), develop regulatory strategies, and manage submissions across multiple jurisdictions. Requires 10+ years in regulated industry with deep expertise in medical device quality standards and regulatory frameworks. PRRC delegation role included.

Exigences clés (estimation)

Supervise regulatory affairs team operations, set objectives, conduct appraisals, and manage performance issues.
Implement compliance with ISO13485, MDD 93/42/EEC, EU MDR 2017/745, FDA 21CFR Part 820, and other jurisdictional requirements.
Plan and prepare regulatory submissions for new products, changes, and re-registrations across target markets.
Develop global regulatory strategies for medical devices, especially high-risk devices, in collaboration with clinical teams.
Communicate with regulatory agencies and notified bodies to ensure timely product clearances and maintain registration systems.
Serve as delegate for Person Responsible for Regulatory Compliance (PRRC) under EU Regulation 2017/745.

Compétences

Regulatory affairs management and compliance expertise (ISO13485, MDD, EU MDR, FDA regulations)Team leadership, performance management, and mentoring capabilitiesRegulatory submission preparation and review across multiple jurisdictionsGlobal regulatory strategy development and stakeholder communicationMedical device quality standards and regulated industry knowledgeProject coordination and organizational skills with attention to detail

Niveau estimé

This is a senior management role requiring 10+ years of professional experience in regulatory affairs or quality management systems within the medical device industry. Candidates must demonstrate extensive knowledge of global regulatory frameworks and proven leadership capabilities.

Attributs détectés par l’IA (si absents de l’offre)

Type de poste: CDI / Temps plein
Mode de travail: Hybride
Niveau d'expérience: 10+ ansConfiance 95%
Fonction: OpérationsConfiance 90%
Secteur: PharmaceutiqueConfiance 85%
Niveau d'études: Licence / Bac+3Confiance 90%
Langues: AnglaisConfiance 95%

Cette analyse a été générée automatiquement par Postule AI à partir de l'offre.

Overview

Lead and supervise the Regulatory Affairs function to ensure smooth, efficient operations within the medical device industry. This role requires deep expertise in global regulatory requirements and the ability to manage a high-performing team while ensuring compliance across multiple jurisdictions.

Main Responsibilities

Supervise day-to-day regulatory affairs team operations, including setting objectives, conducting performance appraisals, developing training plans, and managing performance issues.
Implement and maintain compliance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745, FDA 21CFR Part 820, and other jurisdictional requirements.
Plan, prepare, and review regulatory submissions for new products, product changes, and re-registrations across target markets.
Develop global regulatory strategies for medical devices in collaboration with clinical and regulatory teams, particularly for high-risk devices.
Communicate directly with regional regulatory agencies and notified bodies to ensure timely product clearances and maintain registration systems.
Serve as delegate for Person Responsible for Regulatory Compliance (PRRC) under EU Regulation 2017/745, ensuring technical documentation, declarations of conformity, and post-market surveillance compliance.

Key Requirements

Third-level qualification in Science, Quality, or related field; 10+ years in regulated industry in similar role.
Comprehensive knowledge of GHTF countries and regulatory frameworks (ISO13485, MDD, EU MDR 2017/745, FDA QSP).
Medical device quality standards expertise and familiarity with regulated industry practices.
Strong communication, interpersonal, and problem-solving skills with proven organizational abilities.
Proficiency in Microsoft Office and computer systems; high self-motivation and willingness to travel.
For PRRC role: university degree in law, medicine, pharmacy, engineering, or relevant science with 1+ year RA/QMS experience, or 4+ years professional RA/QMS experience in medical devices.

About This Role

Reporting to the Director of Regulatory Affairs, you will coordinate multiple projects simultaneously, mentor team members, and serve as a liaison between Cook Medical manufacturing, international offices, and distribution partners. You will ensure compliance with Cook's Code of Conduct and maintain regulatory records demonstrating adherence to all applicable regulations.

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