Manager, Certifications

Job Overview
We are seeking a dynamic and detail-oriented Manager, Certifications to lead our certification programs and ensure compliance with industry standards and regulatory requirements. In this pivotal role, you will oversee the development, maintenance, and renewal of product certifications, working closely with cross-functional teams to uphold the highest levels of quality and safety. Your expertise will drive continuous improvement in our certification processes, ensuring our products meet all necessary regulations and market expectations. This position offers an exciting opportunity to influence product integrity and support our commitment to excellence in healthcare and manufacturing.

Duties

• Lead the planning, coordination, and execution of product certification activities across multiple projects, ensuring timely completion and compliance with applicable standards.
• Collaborate with research, manufacturing, quality assurance, and regulatory teams to gather necessary documentation and technical data for certification submissions.
• Maintain up-to-date knowledge of FDA regulations, international standards, and industry best practices related to clinical trials, manufacturing controls, and product safety.
• Manage relationships with certifying bodies and regulatory agencies to facilitate audits, inspections, and renewals.
• Develop and implement robust compliance management systems to monitor ongoing adherence to certification requirements.
• Oversee internal audits related to certifications, identify gaps or areas for improvement, and drive corrective actions.
• Provide training and guidance to internal teams on certification processes, regulatory updates, and quality assurance protocols.

Skills

• Deep understanding of chemistry principles as they relate to manufacturing & controls processes.
• Extensive knowledge of FDA regulations governing medical devices or pharmaceuticals.
• Proven experience managing certifications related to clinical trials and product safety standards.
• Strong project management skills with the ability to coordinate multiple initiatives simultaneously.
• Expertise in research methodologies that support compliance documentation and validation activities.
• Excellent communication skills for liaising with regulatory agencies, internal teams, and external partners.
• Commitment to quality assurance practices that uphold product integrity throughout the development lifecycle. This role is ideal for a motivated professional eager to make a significant impact by ensuring our products meet rigorous certification standards while fostering a culture of continuous improvement. Join us in advancing innovation through compliance excellence!

Pay: $94,000.00 - $115,000.00 per year

Work Location: Hybrid remote in Dallas County, TX