We are seeking a Contract, Regulatory Compliance Specialist II to support product regulatory compliance activities, customer documentation requests, and compliance assessments. The role will collaborate with Regulatory Affairs, Quality, Engineering, Supply Chain, and Product Management teams to ensure products meet applicable global regulatory and customer requirements.
Key Responsibilities & Requirements
- Bachelor’s degree in Engineering, Science, Regulatory Affairs, Environmental Science, or a related technical field.
- 2–5 years of experience in product compliance, regulatory affairs, quality, engineering, or a related field.
- Knowledge of global product compliance regulations and supplier material declarations.
- Proficiency with Microsoft Office and regulatory compliance databases/tools.
- Experience with Greensoft, Assent, or similar platforms is preferred.
- Experience in bioprocessing, life sciences, medical device, or manufacturing is a plus.
- Support compliance assessments, gap analysis, and risk identification.
- Prepare and maintain customer-facing compliance documentation.
- Support RoHS, REACH, PFAS, Conflict Minerals, Proposition 65, and WEEE compliance activities.
- Collect and review supplier declarations and material compliance data.
- Maintain regulatory databases, trackers, and records.
- Support regulatory testing, product labeling, audits, investigations, and corrective actions.
- Participate in new product development and change-control reviews.
- Escalate compliance risks and data gaps to Regulatory Affairs leadership.