Senior Engineer, R&D Compliance

Position Summary 

This position is responsible for leading regulatory compliance, quality engineering strategies, and design history file (DHF) remediation aligned with global medical device standards such as EU MDR, FDA 510(k), ISO 13485, ISO 10993, and ISO 14971. 

Essential Duties & Responsibilities

Material Compliance & Restricted Substances:

• Lead and manage EU MDR-related DHF remediation activities with a focus on legacy material compliance and regulatory gap assessments.
• Author verification and validation (V&V) reports specifically addressing restricted substance evaluations in accordance with global regulatory requirements.
• Act as the primary contact for supplier declarations of conformity, ensuring documentation aligns with material compliance standards and supports international regulatory filings.
• Develop and maintain a comprehensive database of raw materials, capturing compliance attributes across multiple global markets.
• Conduct performance gap assessments related to restricted substances in V&V protocols, production results, and test lab data.
• Review and contribute to Biological Evaluation Reports (BERs), ensuring alignment with restricted substance regulations.
• Monitor emerging global regulations, including PFAS phase-out mandates, Canadian Plastics Registry reporting, and updates to REACH SVHC lists or RoHS exemptions.
• Translate regulatory updates into actionable internal requirements, SOP changes, and risk-based implementation plans.
• Maintain a compliance roadmap and communicate timelines for new regulatory deadlines to internal stakeholder

Regulatory Compliance Testing & Strategy

• Coordinate and execute material and product testing strategies to evaluate compliance with RoHS, REACH, TSCA, POPs Regulation, Prop 65, and Canadian CEPA/Plastics Registry.
• Support internal and external laboratories with the development of test plans for extractable substance screening, PFAS profiling, and analytical assessments required for global regulatory compliance.
• Interpret and document test results in the context of applicable global regulatory limits and thresholds for restricted substances.

Supplier Engagement & Material Disclosure

• Lead supplier outreach initiatives to obtain material disclosure, Full Material Declarations (FMDs), Safety Data Sheets (SDSs), and Substances of Concern in Products (SCIP) notifications as needed for compliance documentation.
• Facilitate supplier audits or technical assessments to verify upstream compliance with restricted substance regulations and sustainability mandates.
• Support supplier onboarding and qualification activities by assessing their capability to provide compliant materials or components under evolving chemical regulations.

Labeling, Documentation & Traceability:

• Collaborate on redline reviews of IFUs, labels, and symbology in compliance with ISO 15223-1 and EU MDR Article 18.
• Assist with cross-functional documentation updates, including Traceability Matrices, Article 18 content, and regulatory Dossiers.
• Write and maintain SOPs supporting material compliance, documentation control, and regulatory alignment.

Cross-Functional Leadership & Project Execution:

• Drive cross-functional collaboration with Procurement, R&D, Program Management, and QA, to ensure cohesive regulatory alignment
• Lead SME review meetings to drive label assignment initiatives and meet compliance timelines.
• Provide regular updates on program progress to the Biocompatibility Manager and Director of Regulatory Affairs.
• Take ownership of challenging project deliverables, ensuring high-quality and timely execution in fast-paced environments.

Post-Market & Risk Management:

• Analyze end-user interface feedback related to material performance and usability risks.
• Support complaint investigations involving material-related issues raised by surgeons or healthcare professionals.
• Review risk documentation (e.g., ISO 14971 risk assessments, pFMEA, RMR) with emphasis on material hazards and restricted substances.
• Prepare and maintain technical documentation, including compliance declarations, risk assessments, and justification dossiers for CE-marking and in