Senior Source Regulatory Compliance Specialist

Johnson & Johnson Innovative Medicine

Cork

Hybrid

EUR 70,000 - 110,000

Full time

3 days ago
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Benefits offered by this job

Annual bonus
Vacation days
Parental leave
Well-being reimbursement
Insurance plans

Job summary

Johnson & Johnson in Cork, Ireland, is seeking a Senior Source Regulatory Compliance Specialist to execute and support regulatory compliance activities related to sourcing, suppliers, and externally provided processes.

You will collaborate with Quality, Regulatory Affairs, Supply Chain and Procurement teams to ensure supplier qualification, audits, and continuous improvement of supplier governance across the region; this role directly impacts audit readiness and product integrity.

Qualifications

  • Bachelor's degree in Regulatory Affairs, Quality, Engineering, Life Sciences, Supply Chain, or related discipline (required).
  • Advanced degree in a scientific or regulatory field (preferred).
  • Typically 4–6 years of experience in Regulatory Compliance, Quality, or related roles within a regulated industry.

Responsibilities

  • Execute source regulatory compliance activities including supplier audit execution and evidence review.
  • Support compliance oversight for suppliers, contract manufacturers, and external services.
  • Partner with Supply Chain, Procurement, Quality, and Regulatory Affairs to support supplier qualification and lifecycle management.
  • Interpret regulatory requirements and translate into sourcing and supplier compliance expectations.
  • Support internal and external audits and health authority inspections.

Skills

Analytical reasoning
Audit experience
Regulatory compliance
Strong communication

Education

Bachelor's degree in Regulatory Affairs, Quality, Engineering, Life Sciences, Supply Chain, or related discipline

Job description

Senior Source Regulatory Compliance Specialist

Hybrid - Cork, Munster, Ireland · County Kilkenny, The Municipal District of Callan — Thomastown, Ireland · Blackpool, England, United Kingdom · Leeds, England, United Kingdom

Sep 16, 2026

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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:

Blackpool, Lancashire, United Kingdom, Cork, Cork, Ireland, Leeds, West Yorkshire, United Kingdom

Job Description:

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.

Job Overview

The Sr. Source Regulatory Compliance Specialistis responsible forexecuting and supporting regulatory compliance activities related to sourcing, suppliers, and externally provided processes. This role ensures that suppliers, contract manufacturers, and sourced materialscomply withapplicable regulatory requirements, quality system standards, and internal policies. The position has a direct impact on product quality, audit readiness, and supply continuity by partnering closely with Quality, Regulatory Affairs, Supply Chain, and Procurement teams across the region.

Key Responsibilities

Execute source regulatory compliance activities including supplier audit execution, investigation approval, and objective evidence review, to ensure adherence to regulatory and quality system requirements

Support compliance oversight for suppliers, contract manufacturers, and externally providedservices.

Partner with Supply Chain, Procurement, Quality, and Regulatory Affairs teams to support compliant supplier qualification and lifecycle management.

Interpret regulatory requirements and support translation into sourcing and supplier compliance expectations.

Support internal audits, external audits, and health authority inspections related to sourcing and supplier compliance.

Monitor compliance risks, trends, and supplier performancemetrics;support corrective and preventive actions.

Ensureaccuratemaintenance of compliance documentation, records, and reports.

Contribute to continuous improvement initiatives to strengthen suppliercompliancegovernance and effectiveness.

Qualifications

Education:

Bachelor’s degree in Regulatory Affairs, Quality, Engineering, Life Sciences, Supply Chain, ora relateddiscipline (required).

Advanced degree in a scientific or regulatory field (preferred).

Experience and Skills:

Required:

Typically4-6years of experience in Regulatory Compliance, Quality, Supply Chain, or related roles within a regulated industry.

Working knowledge of regulatory and quality requirementsimpactingsourcing and supplier operations.

Experienceleadingsupplier audits, inspections, or compliance assessments.

Ability to manage complex compliance topics and documentation with strong attention to detail.

Strong analytical, organizational, and problem‑solving skills.

Effective written and verbal communication skills.

Preferred:

Experience in medical devices, healthcare, or other highly regulated industries.

Familiarity withglobalregulatory and supplier compliance expectations.

Experience working in a global or matrixed organization.

Exposure to regulatory inspections involving supplier or contract manufacturing oversight.

Quality or Regulatory certifications (e.g., RAC, ASQ).

Other:

Travel:moderate regional;limited internationaltravel.

Certifications: Quality or Regulatory certifications preferred but notrequired.

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

Required Skills:

Preferred Skills:

Agile Internal Audit, Analytical Reasoning, Audit and Compliance Trends, Communication, Compliance Management, Compliance Policies, Compliance Risk, Controls Compliance, Critical Thinking, Problem Solving, Quality Auditing, Quality Control (QC), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)

The anticipated base pay range for this position is:

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.

Johnson & J...

Pharmaceutical Manufacturing Chemical Manufacturing Manufacturing

Company size 10,001+ employees

Company type Privately held

Momentum

5% in 12 mo

38,463 employees on LinkedIn

Feb 23 Apr 26

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