Regulatory Affairs Project Leader

We are currently supporting a leading provider of Quality / Regulatory consulting services in the medical device industry.

The team of experts specialise in navigating complex regulatory landscapes to ensure compliance and market access for various medical device clients.

We are seeking a highly skilled Regulatory Affairs Project Leader to join the dynamic team. This role requires a strong understanding of global regulatory requirements, excellent project management skills, and the ability to collaborate effectively with cross-functional teams.

Responsibilities :

• Project Management : Lead and manage regulatory projects for clients from initiation to completion, ensuring adherence to project timelines and deliverables.
• Regulatory Strategy : Develop regulatory strategies tailored to each client's unique needs and product portfolio, including regulatory pathway selection, submission planning, and risk management.
• Regulatory Submissions : Prepare and review regulatory submissions, such as 510(k) premarket notifications, PMA applications, CE Marking applications, and other regulatory filings as required.
• Communication : Serve as the primary point of contact for clients on regulatory matters, providing regular updates and guidance on project status, regulatory changes, and potential risks.
• Cross-Functional Collaboration : Collaborate closely with internal teams, including R&D, Quality Assurance, Clinical Affairs, and Marketing, to ensure alignment on regulatory requirements and project objectives.
• Regulatory Intelligence : Stay abreast of changes in global regulatory requirements, guidance documents, and industry best practices to inform regulatory strategies and ensure compliance.
• Client Management : Build and maintain strong relationships with clients, understanding their business goals and providing strategic regulatory guidance to support their success.

Qualifications :

• Bachelor's degree in a scientific or technical discipline; advanced degree preferred.
• Minimum of 3 years of experience in regulatory affairs within the medical device industry, including experience with regulatory submissions and project management.
• Strong knowledge of global regulatory requirements, including FDA regulations (e.g., 21 CFR Part 820, Part 807), ISO 13485, and EU Medical Device Regulation (MDR).
• Proven track record of successfully managing regulatory projects and achieving regulatory approvals for medical devices.
• Excellent communication and interpersonal skills, with the ability to effectively interact with clients, regulatory agencies, and cross-functional teams.
• Detail-oriented with strong organizational and time management skills.
• Ability to work independently and collaboratively in a fast-paced, dynamic environment.

Benefits :

• Competitive salary
• Comprehensive benefits package
• Opportunities for professional development and growth
• Collaborative and supportive work environment
Vor 27 Tagen