BD

Regulatory Affairs Specialist

BD

full-time

Posted on:

Location Type: Hybrid

Location: Grenoble • France

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Salary

💰 €36,400 - €58,225 per year

About the role

  • Drive alignment between regional regulatory strategies and Business Unit and Country RA objectives within BD’s matrix organization.
  • Prepare and compile registration and/or notification dossiers in collaboration with BU and Country RA teams to support timely submissions and renewals.
  • Lead registration planning and prioritization activities in EMEA to ensure strong alignment with business goals.
  • Execute product launch plans, renewals, and amendments, ensuring adherence to regulatory requirements and approved eIPPRA submissions.
  • Conduct impact assessments for product and regulatory changes within EMEA to ensure continued compliance for medical devices and pharmaceutical products.
  • Maintain Regulatory Information Management (RIM) systems, internal registration databases, and tracking tools to ensure data accuracy and transparency.

Requirements

  • Scientific educational background preferred.
  • 5–10 years of Regulatory Affairs experience, ideally across both Pharmaceutical and Medical Device sectors, with international exposure.
  • Strong organizational, planning, and prioritization skills with the ability to manage multiple tasks.
  • Excellent verbal and written communication skills, with the ability to work cross‑functionally and across cultures.
  • High attention to detail with a focus on accuracy and completeness in all regulatory deliverables.
  • Fluent, native‑level English proficiency; computer‑literate and comfortable working in an international environment.
Benefits
  • Health insurance
  • Retirement plans
  • Paid time off
  • Flexible work arrangements
  • Professional development opportunities
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Regulatory AffairsRegistration planningImpact assessmentsComplianceMedical devicesPharmaceutical productsRegulatory Information Management (RIM)Data accuracySubmission preparationDossier compilation
Soft Skills
Organizational skillsPlanning skillsPrioritization skillsCommunication skillsCross-functional collaborationAttention to detailCultural awarenessTask managementVerbal communicationWritten communication