Qualifications

• Bachelor's degree in a scientific or technical field required; advanced degree preferred.
• 8-10 years of experience in Regulatory Affairs in the medical device sector, with 3-5 years in a leadership role.
• Expertise in submitting regulatory applications like 510(k), PMA, CE Mark.
• In-depth knowledge of FDA regulations and ISO standards relevant to medical devices.
• Strong communication skills for conveying complex regulatory concepts to various stakeholders.
• Demonstrated project management capabilities in a dynamic environment.
• RAC certification is a plus.
• Familiarity with regulatory information management systems.

Responsibilities

• Develop regulatory strategies for new product development and lifecycle management.
• Prepare and submit regulatory documents to health authorities globally.
• Act as the primary contact with regulatory agencies during project phases.
• Interpret regulations and ensure compliance during the commercialization process.
• Lead and mentor junior regulatory affairs team members.
• Participate in audits and provide regulatory guidance.
• Assess the regulatory impact of changes in products and manufacturing processes.
• Collaborate with internal teams to meet regulatory goals.
• Stay updated on regulatory changes and industry trends.

Benefits

• Relocation assistance available for new hires.
• Option to work from home on Fridays.