Director - Regulatory Affairs US

As Director - Regulatory Affairs US, you will be instrumental in establishing Nordberg Medical's presence in the US market, supporting our FDA PMA approval process. Your expertise will ensure that our team fully understands and complies with all necessary processes, ultimately guiding us to achieve successful FDA approval. As our Nordberg Medical sole representative in the US, you will have a tremendous impact on our continued journey as a global pioneer in anti-aging solutions.

Key Responsibilities

Your responsibilities will include, but not be limited to:

• Achieving the company goals for FDA PMA approvals.
• Supporting and leading the process through regulatory discussions & regulatory adherence with FDA and regulatory partner in the US.
• Driving and overseeing CRO activities to align with company objectives.
• Overseeing clinical requirements for ongoing clinical studies in the US as part of the FDA application process.
• Ensuring clinical data integrity and making sure study timelines are consistently met.
• Building and maintaining relationships with key industry stakeholders to support our regulatory and clinical initiatives.
  
  

You will collaborate extensively with our Clinical Affairs Director, Chief Quality & Regulatory Affairs Officer and Senior Advisor to ensure seamless coordination and success in our regulatory endeavors in the US.

Skills and requirements

Qualifications

• Extensive experience in regulatory and clinical affairs within the medical device industry.
• Solid case experience of achieving FDA PMA approval for class III implant, preferably within aesthetics and/or orthopedics.
• Experience within biodegradable and bioabsorbable profiles.
• Experience overseeing and working with CROs.
  
  

Personality

• You bring a resilient, can-do attitude and demonstrate persistence when facing challenges.
• With strong stakeholder management skills, you have a proven ability to influence and build relationships across all levels of the organization and beyond.
• You thrive in collaborative environments, working effectively with both internal and external stakeholders to drive successful outcomes.
• Your work is highly organized and precise, with a keen attention to detail and a structured approach to every task.
  
  

Why should you join our team?

• Growth opportunities: As a key member in establishing our new US team, you'll have the unique opportunity to shape our presence in this critical market. Your contributions will significantly influence our ongoing journey as an innovative and expanding company.
• Continuous learning: We are committed to fostering your professional growth through ongoing training and development opportunities, ensuring you have the resources and support needed for continuous learning and success.
• Entrepreneurial environment: Join a global, inclusive team where innovation and creativity are actively encouraged, empowering you to make a meaningful impact.
• Remote-friendly position: We believe a flexible work environment is only attainable by building strong relationships based on trust with our employees.