Job Summary:

The Regulatory Affairs Specialist will work with product development and manufacturing management to ensure that the product development process meets all applicable regulatory requirements.

Supervisory Responsibilities:

• None.

Duties/Responsibilities:

• Works in the regulatory affairs department on assigned projects.
• Coordinates with product development and/or research and development teams to request, develop, and prepare required data and reports to be submitted to regulatory bodies and agencies.
• Collaborates with key staff from Planning, Product Development, Operations, and Legal departments as required.
• Notifies Regulatory Affairs Manager when compliance issues arise or are identified, when regulatory reports are delayed, and when other immediate action is required.
• Serves as a representative for the regulatory affairs department at process review meetings.
• Establishes and maintains business relationships with officials in federal and state government regulatory agencies.
• Performs other related duties as assigned.

Required Skills/Abilities:

• Extensive knowledge of applicable federal and state regulations and the ability to stay current on regulations.
• Excellent written and verbal communication skills.
• Excellent analytical and problem-solving skills.
• Proficient with Microsoft Office Suite or similar software.

Education and Experience:

• Bachelors degree in related field required.
• Two years of related experience preferred.

Physical Requirements:

• Prolonged periods sitting at a desk and working on a computer.
• Must be able to lift up to 15 pounds at times.