|Restricted Substances Management (RSM) function is responsible for compliance with country-specific chemical regulations impacting Client products/components, or requiring registration of substances used in the manufacture of our products. Examples of impacted regulations are EU REACH, EU RoHS, US Conflict Minerals, China New Chemical Registration, Canadian Chemical Management Plan, etc. |
Primary Function/Primary Goals/Objectives:
This position will be responsible for developing and implementing restricted substance management (RSM) regulatory requirements such as EU Restriction of Hazardous Substances (RoHS), EU Waste Electrical and Electronic Equipment (WEEE), EU REACH, US Conflict Minerals, etc.
- Interacts internally, across multiple functional areas, and externally, with Suppliers and Third Party Manufactures, to obtain restricted substances supporting data to justify business and regulatory needs. Data must be well-organized and stored securely, with log-term retrieval capabilities.
- Reviews and analyzes component and sub-assembly information, assessing for restricted substances impact
- Assembles new EU Restriction of Hazardous Substances (RoHS) Technical File to meet development program timelines; updates existing EU RoHS Technical File periodically (e.g. annually) to reflect parts modification/business change
- Ensures RSM compliance is considered as part of long-term and short-term planning, including lifecycle management and new product introduction
- Works collaboratively with appropriate organizations to facilitate RSM implementation and compliance through the communication of RSM issues and development of process and tools
- Critically evaluates EU Waste Electrical and Electronic Equipment (WEEE) options and makes recommendations to effectively meet requirements in countries where impacted EEE device/combination product is placed on market
- Prepare and update guidelines, policies, procedures, and other documentation to ensure consistent implementation across multiple Client sites and functions
- Proven leadership ability and excellent communication skills
- Self-starter able to work with minimal supervision; results oriented; strong workload organization- and problem-solving skills
- Knowledge of today's key global restricted substances regulations (e.g. EU RoHS, EU REACH); familiarity with pharmaceutical R&D, pharma manufacturing/TPM, and supply chain activities
- Demonstrated team player with ability to work collaboratively with RSM team and functional counterparts in a global environment; ability to influence and solicit cooperation (internally and externally) to meet program objectives
- Strong program management skills and techniques (i.e. plans, schedules, presentations, etc.)
- Competency with Microsoft software suite (e.g. PowerPoint, MS Word, Excel, Outlook)