Job Title: Quality Compliance Manager

Job Description

Work with cross-functional teams to ensure compliance with external standards and regulations. Conduct regulatory assessments to formulate market entry strategies and draft audit responses to address notified body queries. Perform compliance assessments for external standards, regulations and implemented changes to quality systems and products. Goal—Deliver safe and effective medical devices to the global market and to enhance patient outcomes. The Quality Compliance Engineer II is responsible for maintaining the compliance of TMCs products and processes in the changing regulatory landscape. Specifically, the individual will be responsible for supporting the management of Health Hazard Evaluations, tracking of EU MDR deliverables, supporting cross-functional project team with compliance related decisions/interpretations, and evaluating impact of standard/regulation updates to existing product families and QMS processes.

Hard SkillsGlobal experience and understanding regulations for Medical DevicesRegulatory assessment and Product changes/ modificationsGood documentation practices, GDP, validation, and verification/qualificationExpertise in quality management standards, software, and toolsKnowledge of U.S. Food and Drug Administration (FDA) current Good Manufacturing Practice (cGMP) for Medical Devices (21 CFR 820)Knowledge of Health Canada cGMPKnowledge of European MDD and MDRSoft SkillsStrong cross-functional team collaborationIndependent reviewer capabilitiesQuality system and product guidanceCompliance and quality culture reinforcement

Work Site

This is a fully remote position.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.