Senior Source Regulatory Compliance Specialist, Supplier Auditor (m/f/d)

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:
Quality & Compliance Audit

Job Category:
Professional

All Job Posting Locations:
Umkirch, Germany

Job Description:

Job Overview 

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.

The Sr.

Source Regulatory Compliance Specialist is responsible for planning, executing, and supporting supplier audits and related regulatory compliance activities for suppliers, contract manufacturers, and externally provided services and processes.

This role evaluates whether supplier quality systems, sourced materials, and services comply with applicable medical device regulatory requirements, quality system standards, and internal policies.

The position directly supports product quality, audit readiness, and supply continuity by partnering closely with Quality, Regulatory Affairs, Supply Chain, and Procurement teams across the region.

 

Key Responsibilities 

·         Plan, execute, and document Supplier Audits and related Source Regulatory Compliance activities, including investigation approval and objective evidence review, to verify adherence to applicable regulatory and quality system requirements.

·         Partner with Supply Chain, Procurement, Quality, and Regulatory Affairs to execute compliant supplier qualification, lifecycle management, and audit ...