Sr. Spec, Restrictions Mgmt & Automation

Antler Co

Vlaanderen

Hybride

EUR 33 000 - 54 000

Plein temps

Il y a 4 jours

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Avantages offerts par ce poste

Annual bonus

Vacation days

Comprehensive health benefits

Résumé du poste

Johnson & Johnson, a global innovator in healthcare, invites applications for a Sr. Specialist in Restrictions Management & Automation. This hybrid role will be based in Warsaw, Poland, with alternate locations in New Cairo and Diegem, Belgium.

The role leads automated restriction controls enabling compliant, efficient product availability across markets. Close collaboration with Regulatory Affairs, Quality, IT, and regional teams is essential to reduce manual effort and strengthen governance.

Qualifications

Bachelor’s degree required in a related field.
Advanced degree or postgraduate certification preferred.
6–8 years in Quality, Regulatory Affairs, Compliance, or related regulated environment.
Experience managing regulatory or quality‑driven restrictions across multiple markets.
Strong experience with process automation, digital tools, or systems optimization.
Solid understanding of global regulatory frameworks for medical devices.
Ability to analyze complex data and translate requirements into scalable solutions.

Responsabilités

Own global and regional restrictions management processes with accurate interpretation and execution.
Design, implement, and optimize automation and digital solutions to improve efficiency and compliance.
Partner with QARA, Supply Chain and Commercial stakeholders to assess impacts on availability and market access.
Lead data governance activities including master data quality and audit readiness.
Monitor regulatory changes and assess implications for restriction logic and automated controls.
Drive CI initiatives using structured problem‑solving and process optimization.
Provide SME training on restrictions management tools and processes.
Support audits by preparing documentation and responding to inquiries.

Connaissances

Analytical Reasoning

Regulatory Affairs

Data Reporting

Teamwork

Regulatory Compliance

Formation

Bachelor’s degree in Life Sciences, Engineering, Information Systems, Regulatory Affairs, or related field

Advanced degree or relevant postgraduate certification

Outils

SAP

RIM (Regulatory Information Management)

Master Data Systems

Description du poste

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.

Required

Experience and Skills:

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.

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

Required Skills

Analytical Reasoning, Business Behavior, Business Writing, Communication, Confidentiality, Data Reporting, Detail-Oriented, Legal Support, Medicines and Device Development and Regulation, Problem Solving, Product Licensing, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Teamwork

Preferred Skills

The Anticipated Base Pay Range For This Position Is

zł145,800.00 - zł234,600.00

Benefits

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees – and in some location’s eligible dependents – can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.