CQ/RA Specialist

Brighter Signals; Warszawa; In loco; PLN 121.000 - 194.000; Tempo pieno

Vantaggi offerti da questo lavoro

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well‑being reimbursement

Insurance plans

Descrizione del lavoro

Johnson & Johnson is recruiting for a CQ/RA Specialist located in Warsaw, Poland. The role focuses on regulatory and commercial quality compliance for medical devices distributed in the CEE Central Region, supporting patient safety and operational excellence within a complex, global distributor environment.

The candidate will lead QARA projects, coordinate regulatory submissions, and collaborate with Supply Chain, Procurement, and Commercial teams.

Competenze

• Typically 3–5 years of relevant professional experience in quality, regulatory, or distributor‑related activities in a regulated environment.
• Experience managing cross‑functional, multi‑stakeholder projects.
• Working knowledge of quality systems, compliance processes, or regulatory‑driven requirements.
• Ability to communicate clearly with diverse audiences, including senior leadership.
• Proven ability to manage multiple priorities in a fast‑paced, matrix environment.

Mansioni

• Lead and manage QARA projects, ensuring alignment with global and regional quality and regulatory strategies.
• Ensure regulatory clearance of medical devices being in product portfolio of MDs within timelines. Coordination and preparation of product notifications. Managing product submissions.
• Responsible for updates and approvals in systems linked to job duties and maintaining RA databases
• Review of copy review materials for CEE Central region.
• Provide regulatory support to relevant teams and partners - Tender, Health Economics & Reimbursement, Business, Distributors and Franchises and deliver RA trainings to local clusters.
• Provide communication and updates to management regarding regulatory affairs.
• Coordinate cross‑functional stakeholders, including, Supply Chain, Procurement, and Commercial teams, to drive project execution.
• Support implementation and maintenance of distributor quality requirements, including onboarding, oversight, remediation, and continuous improvement activities.
• Prepare and deliver clear project updates, dashboards, and communications to QARA and business leadership.
• Ensure distributor‑related project activities comply with internal quality systems, regulatory requirements, and governance standards.
• Promote a culture of compliance, collaboration, and continuous improvement across distributor management initiatives.

Conoscenze

Project management

Quality systems

Regulatory knowledge

Cross-functional collaboration

Communication

Formazione

Bachelor’s degree in Quality/Regulatory Affairs/Life Sciences/Engineering/Business

Master’s degree or equivalent advanced education preferred

Descrizione del lavoro

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

Quality

Job Sub Function

Customer/Commercial Quality

Job Category

Professional

All Job Posting Locations

Warsaw, Masovian, Poland

Job Description

DePuy Synthes is recruiting for a(n) CQ/RA Specialist, located in Warsaw, Poland.

Job Overview

The CQ/RA Specialist plays a key role within QARA International, responsible for regulatory and commercial quality compliance of medical devices distributed on CEE Central Region market . This role ensures RA and CQ initiatives are delivered on time, in alignment with DePuy Synthes quality systems and regulatory expectations. The position partners closely with Supply Chain, and Commercial teams and directly supports compliance, patient safety, and operational excellence in a complex, global distributor environment.

Key Responsibilities

• Lead and manage QARA projects, ensuring alignment with global and regional quality and regulatory strategies.
• Ensure regulatory clearance of medical devices being in product portfolio of MDs within timelines. Coordination and preparation of product notifications. Managing product submissions.
• Responsible for updates and approvals in systems linked to job duties and maintaining RA databases
• Review of copy review materials for CEE Central region.
• Provide regulatory support to relevant teams and partners - Tender, Health Economics & Reimbursement, Business, Distributors and Franchises and deliver RA trainings to local clusters.
• Provide communication and updates to management regarding regulatory affairs.
• .
• Coordinate cross‑functional stakeholders, including, Supply Chain, Procurement, and Commercial teams, to drive project execution.
• Support implementation and maintenance of distributor quality requirements, including onboarding, oversight, remediation, and continuous improvement activities.
• Prepare and deliver clear project updates, dashboards, and communications to QARA and business leadership.
• Ensure distributor‑related project activities comply with internal quality systems, regulatory requirements, and governance standards.
• Promote a culture of compliance, collaboration, and continuous improvement across distributor management initiatives.

Qualifications

Education

• Bachelor’s degree required in Quality, Regulatory Affairs, Life Sciences, Engineering, Business, or a related discipline.
• Master’s degree or equivalent advanced education preferred.

Required

Experience and Skills

• Typically 3–5 years of relevant professional experience supporting project management, quality, regulatory, or distributor‑related activities in a regulated environment.
• Demonstrated experience managing cross‑functional, multi‑stakeholder projects.
• Working knowledge of quality systems, compliance processes, or regulatory‑driven requirements.
• Ability to communicate clearly with diverse audiences, including senior leadership.
• Proven ability to manage multiple priorities in a fast‑paced, matrix environment.

Preferred

• Experience supporting distributor management or third‑party oversight within medical devices, pharmaceuticals, or healthcare.
• Familiarity with international distributor models and global quality/regulatory expectations.
• Experience with process improvement, remediation, or change management initiatives.
• Knowledge of formal project management methodologies (e.g., PMP, PRINCE2, Agile).
• Strong planning, organizational, and risk‑management skills.

Other

• Language: Fluency in English required; additional languages are an advantage.
• Travel: Limited travel may be required.
• Certifications: Project Management certification preferred but not required.

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.

#DePuySynthesCareers

Preferred Skills

• Audit Management
• Business Behavior
• Coaching
• Compliance Management
• Continuous Improvement
• Data Analysis
• Detail-Oriented
• Goal Attainment
• Internal Controls
• Issue Escalation
• Problem Solving
• Process Oriented
• Quality Control (QC)
• Quality Management Systems (QMS)
• Quality Standards
• Regulatory Environment

The Anticipated Base Pay Range For This Position Is

zł121,000.00 - zł194,350.00

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.

• This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.