Hamilton Medical

Senior Regulatory and Sustainability Compliance Specialist

Hamilton Medical  •  Giarmata, RO (Onsite)  •  1 hour ago
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Job Description

True to the vision "We drive innovation to improve people's lives", the Hamilton companies have been providing solutions for the health sector since 1950. We are an innovative pioneer in the fields of ventilators, automated pipetting, sample management and in the development of process sensors.Hamilton Central Europe is located in Timisoara, Romania and develops and produces microliter syringes, needles, dosing pumps, pipetting modules and accessories for analytical and research laboratories, as well as accessories for medical devices used in intensive care units. In addition, we provide financial accounting services for the Hamilton companies.

  • Track and analyze new and updated requirements related to Material Compliance, including RoHS, REACH, PFAS, TSCA and similar regulations, assessing their impact on products, materials, processes and business operations.
  • Track and analyze new and updated requirements related to Business Compliance & Sustainability regulations, including EUDR, PPWR, CBAM, CSRD, ESPR, Carbon Footprint and related requirements, assessing their impact on products, materials, processes and business operations.
  • Interpret compliance requirements and translate them into operational processes, business rules, internal procedures and practical implementation guidelines.
  • Define, develop and implement the company compliance framework, including mechanisms, processes, responsibilities, controls and monitoring tools to ensure compliance with applicable requirements.
  • Act as the internal subject-matter expert for business compliance, sustainability compliance, product/material compliance and related compliance requirements.
  • Coordinate cross-functional implementation projects, define action plans, assign responsibilities, monitor progress and ensure timely closure of compliance gaps and obligations.
  • Lead and coordinate cross-functional compliance initiatives involving R&D, Engineering, Quality, Purchasing, Supply Chain, Operations, Regulatory Affairs, Sales, Customer Support and other relevant functions to ensure effective and timely implementation of compliance obligations.
  • Collaborate closely and ensure alignment with other Business Units, central functions and relevant stakeholders on compliance standards, reporting expectations, customer requirements and implementation priorities.
  • Perform compliance risk assessments and impact analyses for new products, materials, suppliers, processes and regulatory changes,
  • Identify compliance gaps, define mitigation actions and follow up on corrective and preventive measures until closure.
  • Support Purchasing, Supply Chain and Quality teams in supplier communication related to material declarations, sustainability requirements, restricted substances, product compliance data and regulatory evidence.
  • Plan, conduct and coordinate the execution and follow-up of internal and external compliance audits, including audit findings, corrective actions, evidence collection and management reporting.
  • Support customer requests, questionnaires, declarations and documentation related to product compliance, material compliance, sustainability and business compliance topics.
  • Support the development, maintenance and continuous improvement of compliance-related databases, reporting systems, digital compliance tools and documentation repositories.
  • Contribute to the preparation of internal compliance reports, dashboards, management updates and regulatory status overviews.
  • Develop and deliver compliance training and awareness sessions for relevant functions, ensuring that regulatory requirements are understood and effectively embedded into daily operations.
  • Monitor regulatory trends and emerging requirements, proactively informing management and relevant stakeholders about potential business impacts, risks and required actions.

Professional experience & skills desired to have:

  • At least 5 years of experience in Material Compliance, Business Compliance, Sustainability, ESG or related functions within a manufacturing environment.
  • Very good knowledge of CSRD, CBAM, EUDR, PPWR, CRA, NIS2, ESPR, WEEE and other relevant European sustainability, product and business compliance regulations.
  • Good knowledge of Material Compliance regulations such as RoHS, REACH, TSCA, PFAS and similar regulations.
  • Good understanding of Sustainability, Ethics & Integrity and Corporate Compliance requirements.
  • Proven ability to lead cross-functional initiatives and influence stakeholders across multiple functions and organizational levels without direct reporting authority.
  • Experience implementing compliance requirements in a manufacturing environment.
  • Experience working with suppliers, customers and internal stakeholders on compliance documentation, declarations, evidence collection and compliance implementation topics.
  • Experience with internal audits, compliance assessments, risk evaluations, corrective actions and management reporting.
  • Experience working in a matrix organization and collaborating with global or regional Business Units is considered an advantage.
  • Advanced English.
  • Good project management skills, including planning, prioritization, stakeholder coordination, follow-up and timely closure of actions.
  • Good understanding of digital tools, databases or reporting platforms used for compliance, sustainability, ESG or product/material data management is considered an advantage.
  • Strong ethical standards and integrity.
  • Analytical and critical thinking skills with a structured working style, attention to detail and strong documentation discipline
  • Results-oriented approach.

How to apply:

Send us your resume at jobs.hce.ro@hamilton-ce.com or via the "Apply" button below.

Obtain more information via telephone +40356 635 056 / +40725 707 005

Only suitable candidates will be contacted for interview. Please note that your resume will be entered in our database and may be used in further recruitment projects.

Hamilton Medical

About Hamilton Medical

We live for ventilation technology that helps caregivers improve the lives of their critically ill patients. We believe that innovation is essential to meet the demands of critical care.

To us, innovation is about realizing visionary new ideas and continuously improving existing products, always keeping patient safety and ease of use in focus.

We learn from our customers and from multi-disciplinary experts. And we invest in long-term research and development. We develop Intelligent Ventilation solutions: devices and consumables for the ventilation of all critically ill patients – from neonates to adults.

Industry
Manufacturing & Production
Company Size
501-1,000 employees
Headquarters
Bonaduz, CH
Year Founded
1983
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