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Danaher Corporation Product Compliance Engineer - Chemical Products in Boston, Massachusetts

As a global leader in mass spectrometry, SCIEX delivers solutions for precision detection and quantification of molecules to help protect and advance the wellness and safety of all. Because of our 50 years of groundbreaking innovation, our customers can quickly respond to environmental hazards, better understand biomarkers relevant to disease, improve patient care in the clinic, bring relevant drugs to market faster, and keep food healthier and safer. At SCIEX, you’ll find a rewarding role that amplifies your impact on the world and helps you realize life’s potential.

SCIEX is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.

Do you want to be a part of a dynamic team? Working within the Product Compliance team, this role will support new product development and existing products to ensure SCIEX’s reagents and assays are safe and in adherence to applicable US and international safety and stewardship requirements. This important technical position will have direct influence on R&D and release to market!

This individual will work independently to resolve and develop solutions that are imaginative, detailed, practicable, and consistent with organizational objectives. He/She will bring a proactive, upbeat, “can-do” attitude to a wide range of difficult challenges and be able to interpret and communicate complex regulatory requirements thoughtfully with a logical and practical approach. While the focus of this role is intended to be Chemical products, support of Hardware (Electromechanical) products as well as complex systems comprising of Software and Hardware may also be required.

Documentation and Data Management:

  • Maintain substance data, such as formulation databases and other SDS connected data.

  • Maintain and submit in-country registrations such as ECHA C&L and PCN Notifications, as required.

  • Provide guidance on applicable labeling requirements for chemical products Assist with creation and management of labels, as required.

  • Create TSCA certification documents, Letters of Confirmation (Korea) and other documents as needed.

Technical Leadership skills:

  • Interact and form constructive working relationships within Quality, Marketing, R&D, Systems Engineering and Operations.

  • Act as a trusted advisor and as a project core team member. Communicate and pull in other groups proactively as needed.

  • As a core design team member, communicate applicable technical and design requirements to design teams. Collaborate with team to develop positive and proactive approaches to sustained product compliance.

  • Monitor, interpret, and report status on existing and emerging global requirements with potential to impact SCIEX products. Communicate the product safety and product environmental compliance regulatory impacts.

  • Regularly attend SCIEX and Danaher-level regulatory surveillance meetings to keep abreast of the latest developments in the regulatory landscape and proactively communicate this knowledge with the relevant groups at SCIEX.

  • Independently assess products' chemical composition and classify the products in line with applicable country regulations.

  • Be a champion for continuous improvement by partnering to drive lean processes and improve productivity.

Education and/or Work Experience Requirements:

  • Bachelor’s degree in Chemistry, HSE or Life Sciences field, with 5 years of related experience or Master’s degree in field with 3 years of relevant experience.

  • Knowledge of industry standards/regulations that impact in-vitro medical diagnostic device products.

  • Product Stewardship experience on content, authoring and constraints of SDS documents and labeling requirements.

  • Familiarity with the hazard classification process, understanding the difference between Substance and Mixtures, their breakdown and classification according to country/regional/global regulations.

  • Ability to manage time critical deliverables within established deadlines, taking into account changing business priorities.

Additional Requirements:

  • Knowledge on REACH, K-REACH, Prop 65, WEEE, OSHA, WHMIS, Chemical Inventories, etc

  • Understanding of GHS/CLP classification rules

  • Experience in SDS authoring tools and SDS Author certification

  • Experience working in an ISO 9001/ISO13485 based quality management system environment

  • Work well in a virtual and international team environment

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.

If you’ve ever wondered what’s within you, there’s no better time to find out.

#LI-MH3

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at 202.419.7762 or applyassistance@danaher.com to request accommodation.If you’ve ever wondered what’s within you, there’s no better time to find out.

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