Sr. Spec, Restrictions Mgmt & Automation

Johnson Johnson; Warszawa; Hybrid; PLN 180,000 - 280,000; Full time

Job summary

Johnson & Johnson in Warsaw, Poland, seeks a Sr. Specialist for Restrictions Management & Automation to lead global and regional restriction controls and automated workflows within the QARA International team.

The role focuses on reducing manual effort, increasing transparency, and strengthening governance across markets. The ideal candidate will design scalable automation, partner with Regulatory Affairs, Quality, Supply Chain, and IT/Digital, and drive data-driven decision making.

Qualifications

• Bachelor's degree required (e.g., Life Sciences, Engineering, Information Systems, Regulatory Affairs, or related field).
• Advanced degree or relevant postgraduate certification preferred.

Responsibilities

• Own global and regional restrictions management processes with accurate interpretation and execution.
• Design, implement, and optimize automation and digital solutions for workflows and dashboards.
• Partner with QARA, Supply Chain, and Commercial teams to assess impacts on product availability and market access.
• Lead data governance and master data quality for restrictions and documentation standards.
• Monitor regulatory and quality changes globally and adjust restriction logic and controls.
• Drive continuous improvement through structured problem-solving and process optimization.
• Provide SME training to regional teams on restrictions management tools and processes.
• Support audits and inspections by preparing documentation related to restrictions and automation controls.

Skills

Regulatory compliance

Quality assurance

Data analysis

Process automation

Stakeholder management

Regulatory knowledge

Education

Bachelor's degree

Advanced degree

Tools

SAP

RIM systems

Master data systems

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: Regulatory Affairs Group

Job Sub Function: Regulatory Affairs

Job Category: Professional

All Job Posting Locations: Diegem, Flemish Brabant, Belgium, New Cairo, Cairo, Egypt, Warsaw, Masovian, Poland

Job Description

DePuy Synthes is recruiting for a(n) Sr. Spec, Restrictions Mgmt & Automation , this Hybrid position will be in Warsaw, Poland. Alternate Hybrid locations may be considered at New Cairo, Egypt and Diegem, Belgium.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

Warsaw, Poland - Requisition Number: 097945

New Cairo, Egypt - Requisition Number: 100001

Diegem, Belgium - Requisition Number: 097945

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

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 matri