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