Global Regulatory Strategy Director

As the Global Regulatory Lead at Nordberg Medical, you will play a pivotal role in expanding our market presence by securing product approvals across new global regions, label extensions, minor and major changes to existing approvals and the maintenance of existing approvals. Leveraging your regulatory expertise, you will guide the company through complex international approval processes, collaborating across functions to ensure alignment to commercial priorities, compliance and successful entry into diverse markets.

You will report to our CEO.

Key Responsibilities

Your responsibilities with include but not be limited to:

• Lead regulatory approval efforts for new global markets, with a focus on APAC, LATAM, MENA and CEE
• Develop and execute global regulatory strategies to align with company objectives.
• Collaborate closely with cross-functional teams, including Clinical Affairs, Quality, R&D and Commercial to ensure regulatory compliance and readiness.
• Serve as the primary contact for regulatory authorities, regulatory partners, commercial partners and global industry stakeholders, managing submissions, changes and approvals.
• Oversee the compilation and submission of regulatory documents, ensuring timely and accurate responses to regulatory inquiries.
• Monitor evolving global regulations, adapting strategies and advising leadership accordingly.

Skills & Qualifications

• Extensive experience in global regulatory affairs within the medical device class III industry.
• Demonstrated success in securing market approvals across multiple regions of varying degrees of complexity.
• A business and problem-solving mentality, never taking no for an aswer
• Expertise in biodegradable and bioabsorbable medical devices, preferably in aesthetics and orthopedics.
• Proven ability to manage and lead interactions with regulatory bodies and commercial partners.
• Strong understanding of clinical data requirements and collaboration with CROs.

Personality

• Strategic thinker: You excel at developing and executing comprehensive regulatory plans.
• Collaborative leader: You effectively build relationships with internal and external stakeholders.
• Detail-oriented and organized: Your work is highly organized and precise, with a keen attention to detail and a structured approach to every task.
• Resilient and adaptable: You bring a resilient, can-do attitude and demonstrate persistence when facing challenges.

Other Information

This role requires traveling for business as needed.