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Position Objective
As a Product Environmental Lead, you will be a key member of our team in China, responsible for ensuring compliance with product environmental regulations to support successful market launch of Roche Diagnostics products. This role requires a blend of product stewardship, an understanding of regulatory affairs, solid experience in EH&S Data Management and strong project management skills. You will navigate the complexities of product localization, new product development, and importation for the Chinese market. This position is a unique opportunity for a professional who is fluent in Chinese and English and has a deep understanding of the local culture and business landscape to make a significant impact on our operations in China.
Key Responsibilities
Product Stewardship:
Independently manage product stewardship activities within existing guidelines.
Contribute to project teams, taking ownership of ongoing activities and goals.
Conduct comprehensive product stewardship assessments and support data collection efforts in collaboration with other functions.
Support local sourcing inquiries
Support R&D with setting of environmental product requirements
Environmental Regulatory Compliance/ Implementation:
Apply your in-depth knowledge of environmental regulations affecting Roche Diagnostics products to ensure the compliance of all assigned products in the Chinese market.
Stay informed about changes and updates to local regulations.
Process Application and Development & mQMS:
Work with and improve upon existing processes tied to the mQMS and the direct organization.
Lead process improvements for product stewardship by applying your experience and innovative ideas.
EH&S Data and Insights Management
Validate EH&S and product-related data in alignment with global data standards and local regulatory requirements (e.g. China REACH, GHS, chemical inventory management) to support operations compliance and trade compliance
Support execution of EH&S data management processes according to global governance and procedures.
Generate and analyze data reports to support compliance monitoring, performance tracking, and management decisions.
Support internal and external communication on product compliance and sustainability data.
General Duties:
Develop and conduct training sessions for internal stakeholders.
Contribute to team meetings and participate in relevant discussions.
Act as a key member of the business team, providing insights and support for our operations in China.
Scenario-Specific Responsibilities
For Already Launched & Localized Products:
Oversee the re-assembly process in Suzhou, ensuring compliance for products made in China.
Manage labeling requirements, including China-specific information, and coordinate with the responsible department.
Explore and manage local component sourcing options.
Support the transfer of reagents and assays
For Product Updates:
Lead change management processes for product environmental regulations..
Coordinate with established PCQTs in Europe/US, ensuring they also cover localized products.
Handle notifications and support all re-labeling activities.
For New Product Developments:
Support the transfer of new products to China during the D&D process.
Contribute to sourcing plans for components, including local sourcing options.
Provide support as needed for necessary notifications, registrations, and import license requirements.
For Imported Products:
Be aware of and manage products with different regulatory statuses from the EU/US (e.g., non-IVDs, RUOs).
Required Qualifications
Education:
A minimum of a B.Sc. degree in life sciences, engineering, a related field, or equivalent professional experience.
Professional Experience:
7 years of professional experience with a Bachelor's degree, or 5 years with a Master's degree.
Experience in product stewardship for chemical or medical products, research and development (R&D), or engineering.
A background that includes a mix of Product Stewardship and Commercial Operations is highly desirable.
Knowledge and Skills:
Must be fully fluent in the Chinese language and culture.
Fluent in English.
Strong project management skills.
A foundational understanding of the Environmental product regulation landscape.
In-depth conceptual and practical knowledge in your area of expertise and basic knowledge of related fields.
Stakeholder Management: Ability to use knowledge of your function and key stakeholders to build effective relationships and communicate needs clearly.
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.