Job Board

Responsible for leadership and continuous improvement of North America Regulatory Affairs (RA) activities supporting products and services.

Manages licensure, permits, certifications, and accreditations

Provides regulatory leadership, strategy, and support

Ensures goals, objectives and execution are aligned with DSC and Sector requirements

Provides information, guidance and recommendations to DSC leadership

Agency and customer interface / liaison for regulatory matters

Consultant to Business Development:  provides direction on RA issues related to business pursuits

Supports Regulatory Director with site compliance with federal and state regulatory requirements.  Serves as subject matter expert on product-related regulations, standards, and codes (e.g., FDA, DEA, ATF, BOP, USDA, etc.).  Interprets regulatory requirements and actions required for compliance.

Provides leadership and direction to ensure effective implementation, application, and continuous improvement of regulatory activities and ensures alignment and compliance with Global Quality and Regulatory initiatives.

Supports and reviews continuous improvement opportunities with regulatory processes for licensure, permits, certifications, and accreditations

Advisor to Senior Management and Customers on regulatory issues/initiatives, including problemsolving, business pursuits, strategic direction, and significant issues. Ensures goals, objectives and execution are aligned with DSC and BU requirements

Provides information, guidance and recommendations to DSC leadership

Provided direction on regulatory and quality issues related to business pursuits

Engaged with site level support to quality and operations personnel as required 

Provide oversight to operations with implementation and training on RA processes and procedures

Provides guidance and resources to support operations with external audits from regulators

Develop, maintain and continually improve site level training on regulatory, quality and the systems used to deploy training

Verify and analyze regulatory metrics and create executive management reporting

Support Project Delivery team with licensing and other regulatory matters required for a successful start-up

Perform other duties as necessary

Bachelor’s degree in related field

MBA or higher level degree

Quality or Regulatory certified training