Sr. Spec, Restrictions Mgmt & Automation

Job Overview 

This role sits within QARA International and plays a critical part in enabling compliant, efficient global product availability. The Sr. Specialist, Restrictions Management & Automation leads the execution and continuous improvement of restriction controls, digital workflows, and automation solutions that support regulatory compliance, market access, and supply continuity across international markets. The role partners closely with Regulatory Affairs, Quality, Supply Chain, IT/Digital, and regional teams to reduce manual effort, increase transparency, and strengthen governance through scalable, automated solutions. 

Key Responsibilities 

• Own and manage global and regional restrictions management processes, ensuring accurate interpretation, documentation, and execution of regulatory and quality‑driven restrictions. 

• Design, implement, and optimize automation and digital solutions (e.g., workflows, dashboards, rule‑based controls) to improve efficiency, accuracy, and compliance. 

• Partner with QARA, Supply Chain, and Commercial stakeholders to assess restriction impacts on product availability and market access, and support risk‑based decision making. 

• Lead data governance activities related to restrictions, including master data quality, documentation standards, and audit readiness. 

• Monitor regulatory and quality changes globally and assess implications for existing restriction logic and automated controls. 

• Drive continuous improvement initiatives using structured problem‑solving and process optimization methodologies. 

• Provide subject matter expertise and training to regional teams on restrictions management tools and processes. 

• Support internal and external audits and inspections by preparing documentation and responding to inquiries related to restrictions and automation controls. 

Qualifications 

Education: 

• Bachelor’s degree required (e.g., Life Sciences, Engineering, Information Systems, Regulatory Affairs, or related field). 

• Advanced degree or relevant postgraduate certification preferred. 

Experience and Skills: 

Required: 

• Typically 6–8 years of professional experience in Quality, Regulatory Affairs, Compliance, Supply Chain, or related regulated‑industry environment, consistent with a senior specialist level. 

• Demonstrated experience managing regulatory or quality‑driven restrictions across multiple markets. 

• Strong experience with process automation, digital tools, or systems optimization (e.g., workflow tools, data management platforms). 

• Solid understanding of global regulatory frameworks applicable to medical devices. 

• Proven ability to analyze complex data, identify risks, and translate requirements into scalable solutions. 

Preferred: 

• Experience within medical devices or other highly regulated healthcare industries. 

• Hands‑on experience with automation, RPA, or low‑code/no‑code platforms. 

• Familiarity with SAP, regulatory information management (RIM), or master data systems. 

• Experience supporting audits and inspections at a regional or global level.\ 

• Strong stakeholder management, communication, and documentation skills in a matrixed, international environment. 

Other: 

• Languages: Fluency in English required; additional European languages preferred. 

• Travel: Limited; Up to ~10% international travel may be required. 

• Certifications: Regulatory Affairs, Quality, Lean, Six Sigma, or automation‑related certifications preferred. 

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.