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The Contract, Regulatory Compliance Specialist II supports the Regulatory Affairs team by assisting with product compliance activities, customer compliance documentation requests, regulatory data collection, and compliance assessments. This role works closely with cross-functional teams to help ensure products and documentation meet applicable regulatory and customer requirements. The Contract, Regulatory Compliance Specialist II contributes to compliance projects, supports gap assessments, and escalates potential compliance risks to senior team members as appropriate.

Responsibilities

The Contract, Regulatory Compliance Specialist II must be able to:

• Support product compliance assessments and assist with identifying compliance gaps and potential risks.
• Prepare and maintain product compliance documentation in response to customer requests.
• Assist with regulatory compliance activities related to RoHS, REACH, PFAS, Conflict Minerals, Proposition 65, WEEE, and other applicable regulations.
• Participate in new product development and change control reviews to support product compliance requirements.
• Collect, review, and organize supplier compliance data and declarations.
• Assist in the maintenance of regulatory compliance databases, trackers, and records.
• Support regulatory testing activities by coordinating documentation, sample submissions, and follow-up activities.
• Assist with the review of product labeling and documentation for compliance with applicable regulatory requirements.
• Collaborate with Quality, Engineering, Supply Chain, and Product Management teams on compliance-related activities.
• Support investigations, corrective actions, and continuous improvement initiatives related to product compliance.
• Escalate compliance concerns, risks, or data gaps to Regulatory Affairs management in a timely manner.
• Support internal and external audits by providing requested compliance documentation and records.
• Promote a quality and compliance-focused culture throughout the organization.
• Perform other regulatory and compliance support activities as assigned.

Education/Work Experience Requirements

• Bachelor's degree in Engineering, Science, Regulatory Affairs, Environmental Science, or a related technical discipline.
• 2 to 5 years of experience in product compliance, regulatory affairs, quality, engineering, or a related field within the life sciences, biopharmaceutical, medical device, or manufacturing industry.
• Working knowledge of product compliance regulations such as RoHS, REACH, Conflict Minerals, Proposition 65, WEEE, PFAS, and related global regulatory requirements.
• Strong written and verbal communication skills.
• Ability to work effectively with cross-functional teams and global stakeholders.
• Strong organizational skills and attention to detail.
• Ability to manage multiple tasks and prioritize work effectively.
• Proficient in Microsoft Office applications and regulatory compliance databases/tools.
• Problem-solving skills with the ability to identify issues and escalate appropriately.
• Willingness to learn new regulations and compliance requirements.

Preferred Qualifications

• Experience supporting customer compliance documentation requests.
• Experience working with supplier compliance data and material declarations.
• Familiarity with regulatory compliance platforms such as Greensoft, Assent, or similar systems.
• Experience within the bioprocessing, life sciences, or medical device industry.