Director of Regulatory Affairs

PTS Diagnostics • Whitestown, IN

94d • Remote

About The Position

The position is responsible for all matters related to regulatory affairs, including coordinating and facilitating US regulatory submissions and international regulatory registrations. The role involves filing for and maintaining CLIA waivers, approving product labeling, and providing guidance on regulatory requirements for business partners and internal customers. The individual will also be responsible for US Medical Device Reporting and global vigilance reporting, serving as the European Person Responsible for Regulatory Compliance. Collaboration with Sinocare and sister companies to support inter-company projects is also a key aspect of the role.

Requirements

• Bachelor of Science in Chemistry, Biology, Medical Technology, Engineering, or related area from an accredited four-year college or university.
• Fifteen years related experience with in vitro diagnostics (IVDs) or equivalent combination of education and experience.
• Clinical laboratory experience highly desired.
• RAC certification preferred.
• Strong scientifically based background.

Responsibilities

• Be responsible for all matters related to regulatory affairs.
• Coordinate and facilitate US regulatory submissions and international regulatory registrations.
• File for and maintain CLIA waivers when needed.
• Approve product labeling, ensuring compliance with requirements.
• Participate in review, approval, and implementation of product changes.
• Provide guidance on regulatory requirements for business partners and internal customers.
• Provide advice and strategy planning regarding compliance issues related to the FDA and OUS regulatory requirements.
• Be responsible for US Medical Device Reporting and global vigilance reporting.
• Serve as European Person Responsible for Regulatory Compliance.
• Collaborate with Sinocare and sister company to support inter-company projects.
• Write, update, and file US regulatory submissions including 510(k)'s, CLIA submissions and FDA correspondence.
• File and update international regulatory submissions and product registrations/licensing.
• Develop the timeline for US-FDA and international submissions based on marketing and sales strategic plans.
• Work with colleagues to outline data submission requirements.
• Coordinate the collection of technical data to support submissions as part of the Project Team.
• Provide global regulatory strategies for new and modified products.
• Interface with executive management regarding applicable regulations and ensure regulatory compliance.
• Interface with all functional areas to advise on and assist with compliance matters.
• Provide direction and guidance in the interpretation of FDA Medical Device Reporting and other market regulations.
• Maintain product technical files and documentation as required.
• Maintain registrations in foreign countries and ensure compliance with shipment regulations.
• Act as company representative for all product/quality system regulatory agencies.
• Adhere to all workplace safety laws, regulations, standards, and practices.
• Remain current and compliant with all training requirements.

Benefits

• Equal Opportunity Employer
• E-Verify employer

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 101-250 employees