Regulatory Affairs Manager

This opportunity is with a company revolutionizing the medical device industry with its cutting-edge technologies and commitment to addressing unmet healthcare needs. At the heart of their success is the culture of innovation. The company fosters a dynamic environment where creativity and collaboration thrive. With a diverse team of engineers, researchers, and industry experts, they are continuously pushing the boundaries of what's possible in medical device design and development.

Responsibilities:

• Develop and execute regulatory strategies for both local and global expansion initiatives.
• Keep abreast of evolving compliance protocols and regulatory enforcement trends.
• Monitor regulatory updates globally and adhere to new international standards.
• Coordinate document compilation for product registrations, licenses, and notifications to regulatory bodies.
• Research and stay informed about new regulations and submission requirements across various markets.
• Assist the business development team by fulfilling document requests.
• Offer regulatory guidance throughout product development, including preparing justifications for non-filing.
• Assess new and modified devices to ensure compliance with premarket regulations.
• Oversee the development and implementation of post-market surveillance strategies.
• Manage vigilance procedures, investigations, and reporting obligations.
• Maintain accurate domestic and international registrations and product listings.
• Collaborate with Quality functions as necessary, including handling investigations and audits.
• Cultivate relationships with regulatory bodies and representatives.
• Review contracts related to distribution, authorized representation, and regulatory compliance.

Qualifications:

• Bachelor’s Degree required.
• 5 years of experience in the medical device industry
• Familiarity with ICH, FDA regulations, ISO 13485, MDSAP, and other relevant standards.
• Self-driven with strong problem-solving abilities.
• Excellent communication skills, both written and verbal.
• Willing and able to work fully in-person or on a hybrid schedule in Indiana