At Thermo Fisher Scientific, Product Legislation Compliance (PLC) comprises management of global product safety, product environmental and chemical regulations. This role will be primarily responsible for managing the PLC program for the Clinical Diagnostics Division (CDD). This involves maintaining global awareness of regulatory trends affecting the business, communicating operational implications and providing oversight and monitoring of the business compliance programs. The incumbent will be expected to build a program that proactively works across all sites/business units and effectively communicates and coordinates projects across multiple functions including Research and Development, Engineering, Manufacturing Operations, and Environmental Health & Safety colleagues.

Key Responsibilities:

• Develop and Implement project oversight structure, tasks, deliverables, dependencies and resource requirements for PLC management
• Single point of contact and owner/council member of appropriate software to manage PLC and related data bases such as WERCS for SDS management
• Prepare updates to Leadership on PLC programs. Develop and maintain relevant metrics to measure compliance

• Identify, document, and communicate product risks and contingency plans
• Partner with R&D and other related departments to drive innovation of products to avoid formulations which include Substances of Very High Concern or similar hazards
• Lead all efforts in assuring substance registrations in global markets
• Develop and maintain infrastructure to track product formulations and operational chemical inventories
• Develop and maintain infrastructure to ensure compliance with all product environmental compliance requirements (e.g. Full Material Declarations) such as SVHC notifications and reporting (e.g. SCIP Database), RoHS-like regulations and U.S. Prop 65
• Oversee select product safety programs necessary to attain and maintain international certifications such as CE and NRTL Marking
• Conduct internal audits of CDD sites to identify site gaps in product legislation compliance
• Act as principle liaison between the CDD business and corporate PLC leadership
• Manage all aspects of Material Safety Data Sheets (SDS) across all of CDD
• Tracking and communicating status, plans, issues, timelines, action items, and budgets
• Facilitating project team meetings, cross-functional communication and decision making, ensuring alignment with internal and external stakeholders
• Exercising scope management with consideration for the customer, team, and company needs
• Promoting a proactive, professional culture and contributing to overall product compliance. This will include input into country/regional legislation that may/will affect CDDs product portfolio. Participate in Corporate sponsored product legislation Kaizen activities

Minimum Requirements/Qualifications:

• Bachelor’s degree in chemical sciences, chemical engineering, or related field or equivalent
• Demonstrable experience working with the framework of chemical regulations within EU and US (e.g. REACH, CLP, TSCA, HazComm 2012) with proven knowledge of niche regulations such as BPR, PIC, & FIFRA is highly preferred. Experience working with other international product compliance laws (e.g. HPR, WHMIS, K-REACH, MEP-7, CSCL, etc.) is desired.
• 7 years industry experience including 5 years’ experience in product legislation roles, including chemical compliance, environmental compliance and instrumentation safety
• Understanding of quality system standards and regulatory compliance requirements for medical device or diagnostics
• Technical skills in manufacturing techniques, FDA & GMP compliance
• Demonstrated skills using MS Project or related software for Project Management in addition to environmental compliance software as a service tool
• Solid skills using SAP, Agile, MS Office, Outlook, and the Internet.
• Domestic/international travel (~30 - 40%)

Non-Negotiable Hiring Criteria:

• Superior organizational skills with ability to multi-task and balance complex and routine work activities
• Demonstrated ability to lead, direct and manage cross-functional teams, influence business partners and get results through others. High-level business acumen
• Advanced interpersonal and communication skills, both written and verbal, with the ability to work as a team player and team builder
• Excellent communication skills for group presentations and intercompany written and verbal communications
• Demonstrated experience using financial reports, budgeting and other related reporting tools