Senior Director, Regulatory Affairs Operations

Maroc

Publié il y a moins de 7 jours

Décryptage du poste par Postule AI

Résumé du rôle

Cook Medical seeks a Senior Director to lead global Regulatory Affairs Operations strategy, governance, and execution. This executive role oversees multi-layered global teams across manufacturing support, operations, and regional functions, ensuring compliance and operational excellence across all markets. The ideal candidate brings 15+ years in regulated industries, deep medical device regulatory expertise (FDA, EU, ISO standards), strong global team leadership, and emerging proficiency in AI and digital transformation tools.

Exigences clés (estimation)

Direct and maintain scalable global Regulatory Affairs Operations structure with clear communication and alignment to regional regulatory needs and business objectives.
Develop and lead strategic vision for global Regulatory Affairs Operations team, ensuring alignment with corporate goals, regulatory requirements, and operational excellence
Provide leadership, mentorship, and technical expertise to geographically dispersed teams, ensuring alignment with global standards and regional needs.
Oversee and manage Regulatory Affairs Operations budgets, cost tracking, and strategic planning to support global operational priorities.
Drive contract and due-diligence review processes, including non-Cook-labelled submissions and divestiture-related strategy with internal stakeholders.
Oversee Regional Support teams responsible for local regulatory representation, including Canadian and EU Representative duties and regulator consultations.

Compétences

Comprehensive understanding of medical device regulatory standards (ISO13485, MDD 93/42/EEC, EU MDR 2017/745, FDA QSR 21 CFR).Strong global team leadership and multi-layered team management with proven success developing diverse teams.Working knowledge of Regulatory Information Management Systems (RIMS) and digital/AI tools for regulatory operations.Fluency in Artificial Intelligence and data concepts, including ability to evaluate AI outputs and communicate insights responsibly.Ability to lead multiple complex global projects simultaneously and deliver within deadlines.Excellent stakeholder engagement and relationship-building across diverse geographies and cultures.Strategic problem-solving and organizational planning with keen attention to detail.Adaptability to dynamic landscapes and organizational changes with flexibility across global time zones.

Niveau estimé

This is a senior executive role requiring minimum 15 years in regulated industries with significant regulatory affairs operations and global team leadership experience. The position demands strategic expertise, proven ability to manage complex multi-layered organizations, and emerging proficiency in AI and digital tools.

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

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

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

Overview

The Senior Director, Regulatory Affairs Operations leads the global strategy, governance, and operational execution of Regulatory Affairs Operations, ensuring compliance, efficiency, and continuous improvement across markets through standardized systems and processes. This role leads and inspires global teams across Regulatory Affairs Manufacturing Support Services, Regulatory Affairs Operations, and Regional Support functions, fostering a culture of collaboration, accountability, and high performance.

Main Responsibilities

Direct and maintain a scalable, global structure for Regulatory Affairs Operations, ensuring clear communication and alignment with regional regulatory needs and business objectives.
Develop and lead the strategic vision and objectives for the global Regulatory Affairs Operations team, ensuring alignment with corporate goals, regulatory requirements, and operational excellence initiatives.
Provide leadership, mentorship, and technical expertise to a diverse, geographically dispersed Regulatory Affairs Operations team, ensuring alignment with global standards and regional needs.
Oversee and manage Regulatory Affairs Operations budgets, including cost tracking and strategic planning to support global operational priorities.
Drive contract and due-diligence review processes, including non-Cook-labelled submissions and divestiture-related strategy, partnering with internal stakeholders on product or process changes.
Oversee Regional Support teams responsible for local regulatory representation, including Canadian Representative and EU Representative duties, and regulator consultations with agencies and health authorities.

Key Requirements

Bachelor's degree in Science or Engineering required.
Minimum 15 years' experience in a regulated industry, including significant experience in regulatory affairs operations and leading multi-layered, global teams.
Comprehensive understanding of medical device regulatory standards: ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745, and FDA QSR 21 CFR.
Working knowledge of Regulatory Information Management Systems (RIMS) and related digital and AI tools.
Strong leadership and team management capabilities with demonstrated success guiding global, multi-layered teams.
Ability to lead and deliver multiple complex global projects simultaneously within deadlines.
Fluency in Artificial Intelligence (AI) and data concepts, including ability to critically evaluate AI outputs and communicate AI-driven insights responsibly.
Excellent communication and interpersonal skills to build relationships across diverse geographies and cultures.

Additional Expectations

Engage effectively with stakeholders across all levels of the global organization, including regional regulatory agencies, to foster strategic relationships and ensure compliance.
Champion continuous improvement culture by leading initiatives that leverage AI, digital tools, automation, and process innovation.
Lead initiatives for risk mitigation and proactive adaptation of Regulatory Affairs Operations strategies at a global level.
Foster a high-performance culture focused on talent development, succession planning, and continuous improvement.
Willingness and availability to travel globally on company business and flexibility to work across global time zones.

Cette description d'emploi a pu être reformatée par Postule pour améliorer sa lisibilité et sa présentation. Le contenu et les informations restent fidèles à l'offre d'emploi originale. .

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