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**Job Function: **
Quality
**Job Sub Function: **
Quality Assurance
Job Category:
People Leader
All Job Posting Locations:
Solna, Stockholm County, Sweden
Job Description:
DePuy Synthes is recruiting for a(n) LOC Sr. Regulatory Compliance Specialist EMEA, this hybrid position is located in Zuchwil, Solothurn.
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):
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
Johnson & Johnson announced plans to separate our Orthopedics business to establish a standalone orthopedics 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 announced plans to separate our Orthopedics business to establish a standalone orthopedics 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 LOC Sr. Regulatory Compliance Specialist (EMEA) is responsible for leading and executing regulatory compliance activities for the Local Operating Company (LOC) within the EMEA region. This role ensures adherence to applicable regulatory requirements, quality system standards, and internal policies across local commercial and distribution operations. The position plays a key role in safeguarding patient safety, maintaining regulatory readiness, and enabling compliant business operations by partnering closely with Quality, Regulatory Affairs, Commercial, and Supply Chain teams.
Key Responsibilities
Lead and execute regulatory compliance activities for the local operating company in alignment with global and regional requirements.
Support Schedule development of internal audits in the region, support response development, and track action to point of completion
Ensure adherence to EMEA and country‑specific regulatory requirements, internal policies, and quality system standards.
Partner with Regulatory Affairs, Quality, Commercial, and Supply Chain teams to support compliant product distribution and lifecycle activities.
Interpret regulatory requirements and translate them into practical compliance guidance for local stakeholders.
Support internal audits, external audits, and health authority inspections at the local level.
Monitor compliance risks, trends, and performance metrics and support corrective and preventive actions.
Ensure accurate maintenance of compliance documentation, records, and reports.
Contribute to continuous improvement initiatives to strengthen regulatory compliance maturity within the LOC.
Qualifications
Education:
Bachelor’s degree in Regulatory Affairs, Quality, Engineering, Life Sciences, or a related discipline (required).
Advanced degree in a scientific or regulatory field (preferred).
Experience and Skills:
Required:
Typically 4-6 years of experience in Regulatory Compliance, Quality, or related roles within a regulated industry.
Strong working knowledge of regulatory and compliance requirements applicable to EMEA local operations.
Experience supporting audits, inspections, or compliance assessments.
Ability to manage complex compliance topics with strong attention to detail.
Preferred:
Experience in medical devices, healthcare, or other highly regulated industries.
Familiarity with EU MDR and EMEA regulatory compliance expectations.
Experience working in a global or matrixed organization.
Exposure to regulatory inspections involving local operating companies.
Quality or Regulatory certifications (e.g., RAC, ASQ).
Strong analytical, organizational, and problem‑solving skills.
Effective written and verbal communication skills.
Other:
Language: English required; additional European languages preferred.
Travel: Limited; occasional regional travel within EMEA.
Certifications: Quality or Regulatory certifications 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.
#DePuySynthesCareers
#LI-Hybrid
**Required Skills: **
Preferred Skills:
Business Savvy, Compliance Management, Corrective and Preventive Action (CAPA), Cross-Functional Collaboration, Developing Others, Fact-Based Decision Making, Give Feedback, Human-Centered Design, Inclusive Leadership, ISO 9001, Leadership, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Risk Assessments, Standard Operating Procedure (SOP), Team Management