Regulatory Affairs Specialist

Health Marketing; Warsaw (IN); On-site; USD 120,000 - 150,000; Full time

Job summary

Health Marketing in Warsaw, Indiana is seeking an experienced Regulatory Affairs Manager to lead submissions and maintain compliance for medical device products. You will coordinate with regulatory bodies, manage post-market surveillance, and ensure alignment with quality system standards.

You will perform audits, review technical files, support staff training, and advise stakeholders on regulatory risks, enabling safe and compliant market access across domestic and international regulations.

Qualifications

• Knowledge of medical device regulations and quality systems.
• Strong understanding of regulatory submission processes and compliance management.
• Excellent communication and coordination abilities.
• Attention to detail in audits, reviews, and investigations.

Responsibilities

• Managing submissions, registrations, and listings for medical devices.
• Conducting complaint investigations, product reviews, and post-market surveillance.
• Performing audits and reviewing technical files to ensure compliance.
• Supporting staff training on regulatory requirements.
• Coordinating with regulatory agencies and advising stakeholders on compliance risks.
• Ensuring adherence to domestic and international regulations and quality system standards.

Skills

Regulatory knowledge

Regulatory submissions

Communication

Attention to detail

Job description

Role: Regulatory Affairs Manager for medical device products.

Responsibilities Include

• Managing submissions, registrations, and listings for medical devices.
• Conducting complaint investigations, product reviews, and post-market surveillance.
• Performing audits and reviewing technical files to ensure compliance.
• Supporting staff training on regulatory requirements.
• Coordinating with regulatory agencies and advising stakeholders on compliance risks.
• Ensuring adherence to domestic and international regulations and quality system standards.

Qualifications & Skills

• Knowledge of medical device regulations and quality systems.
• Strong understanding of regulatory submission processes and compliance management.
• Excellent communication and coordination abilities.
• Attention to detail in audits, reviews, and investigations.