Quality and Regulatory Affairs Manager developing and supporting quality management systems for medical devices. Engaging in regulatory processes and facilitating innovation in healthcare.
About the role
- Global Trade Operations Leader overseeing North American Trade Operations and Global Sanctions Programs. Focused on trade compliance and building strategic partnerships.
Responsibilities
- Own and execute the operational trade strategy for North America, including import/export controls, broker management, and service provider oversight.
- Lead the development and implementation of effective controls for high-impact processes, ensuring alignment with internal control frameworks.
- Coordinate global and regional trade compliance risk assessments and implement mitigation plans in collaboration with the Director of Global Trade and Trade Data & Risk Management teams.
- Manage export licensing, jurisdictional determinations, and technology control plans.
- Oversee the Global Sanctions program, including service provider compliance and escalation procedures.
- Manage and escalate issues related to global sanctions, restricted party screening, and anti-boycott regulations.
- Build strategic partnerships across key functions including Sourcing, Planning, Sales, Customer Service, Warehouse, Manufacturing, Engineering, Finance, Tax, Accounting, Sustainability, EH&S, and Legal.
- Ensure compliance with U.S. CBP, CBSA, BIS, and other relevant authorities across North America.
- Lead internal audits and assessments to evaluate control effectiveness and regulatory adherence.
Requirements
- Undergraduate degree, advanced degree (i.e. MBA) or other significant industry experience such as U.S. Customs Broker License required
- At least 10 years relevant experience in logistics, trade compliance or a related field
- Experience working in a multinational company with cross-functional collaboration that relies heavily on relationship building to succeed.
Benefits
- insurance (medical/dental/vision/life/disability/supplemental offerings)
- 401k (company contribution regardless of employee participation – plus match)
- liberal paid time off (vacation, personal floating and standard holidays)
- Employee Assistance Services
- Stock Purchase Program – and more
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