LOC Sr. Reg Compliance Specialist EMEA
Hybrid · Solna, Stockholm, Sweden
Job Summary
LOC Sr. Regulatory Compliance Specialist (EMEA) leads and executes regulatory compliance activities for the local operating company within the EMEA region, ensuring adherence to regulatory requirements, quality system standards, and internal policies across local commercial and distribution operations. Partners with Quality, Regulatory Affairs, Commercial, and Supply Chain to support compliant product distribution and lifecycle activities; interprets regulatory requirements into practical guidance for local stakeholders; supports internal and external audits and health authority inspections; monitors compliance risks and performance metrics; maintains compliance documentation and records; contributes to continuous improvement of regulatory compliance maturity within the LOC.
Required Qualifications
- Bachelor’s degree in Regulatory Affairs, Quality, Engineering, Life Sciences, 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 (required)
- Strong working knowledge of regulatory and compliance requirements applicable to EMEA local operations (required)
- Experience supporting audits, inspections, or compliance assessments (required)
- Ability to manage complex compliance topics with strong attention to detail (required)
- Preferred: Experience in medical devices, healthcare, or other highly regulated industries (preferred)
- Familiarity with EU MDR and EMEA regulatory compliance expectations (preferred)
- Experience working in a global or matrixed organization (preferred)
- Exposure to regulatory inspections involving local operating companies (preferred)
- Quality or Regulatory certifications (e.g., RAC, ASQ) (preferred)
- Strong analytical, organizational, and problem-solving skills (required)
- Effective written and verbal communication skills (required)
- Language: English required; additional European languages preferred (required)
- Travel: Limited; occasional regional travel within EMEA (required)
- Certifications: Quality or Regulatory certifications preferred but not required (preferred)
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