About us:

For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.

Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenges, you may be a perfect fit for our team!

Position Summary:

We are seeking a highly skilled and detail-oriented ESG Compliance Specialist with subject matter expertise (SME) in global environmental compliance and material regulations. This role will focus on ensuring that all electronic and mechanical components used in our products meet applicable regulatory and environmental standards. The ideal candidate will be the go-to expert on international substance and material compliance directives including EU RoHS, EU REACH, California Prop 65, PFAS, Conflict Minerals, EU Waste Framework, and EU MDR.

Key Responsibilities:

Serve as the SME for environmental and material compliance regulations: EU RoHS (Restriction of Hazardous Substances) EU REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) California Proposition 65 PFAS (Per- and Polyfluoroalkyl Substances) Identification and Risk Assessment Conflict Minerals Reporting and Due Diligence EU Waste Framework Directive (SCIP database submissions) EU MDR (Medical Device Regulation) materials compliance Evaluate and approve components and materials used in new and existing designs for regulatory compliance. Collaborate with suppliers to collect and validate compliance documentation (e.g., Full Material Declarations, Certificates of Compliance). Maintain and update internal compliance databases and product lifecycle tools. Work cross-functionally with design engineering, quality, procurement, legal, and regulatory teams to ensure product conformity. Conduct gap analysis on new or updated environmental regulations and implement internal policy changes as needed. Support audits, internal reviews, and customer inquiries regarding material compliance. Create and deliver training and guidance materials on regulatory compliance to internal teams.

Must Have:

Bachelor’s degree in Electrical, Mechanical, Materials Engineering, or related field. 5+ years of experience in component engineering, materials compliance, or regulatory affairs. Deep knowledge and hands-on experience with: EU RoHS, EU REACH, California Prop 65, PFAS identification methods, Conflict Minerals (CMRT/EMRT), SCIP submissions, EU MDR. Familiarity with product compliance databases (e.g., SiliconExpert, BOMCheck, Assent, IPC-1752A). Strong analytical, documentation, and communication skills. Ability to interpret and apply international regulations to complex component data. Proven ability to collaborate in a cross-functional, global environment. Valid US Travel Visa

Good to have:

Experience in the medical device industry. Knowledge of ISO 13485, IEC 62474, or similar standards. Professional certifications related to regulatory compliance or sustainability (e.g., REACH/RoHS specialist).

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec’s goal to create a great work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Our benefits include Training and career development, Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.