Regional Regulatory Operations Specialist
jj · Maroussi - Athens
Περιγραφή θέσης
About the role
Johnson & Johnson's Surgery team develops surgical technologies and solutions for surgeons and healthcare professionals worldwide, targeting conditions such as obesity, cardiovascular disease and cancer. This Regional Regulatory Operations Specialist provides centralized regulatory operational support to ensure regulatory compliance, data accuracy and product availability across supported markets. The role manages regulatory data and documentation, supports product lifecycle activities, facilitates tender and customer requests, and proactively resolves regulatory data issues affecting commercialization and supply continuity.
Key responsibilities
- Product eligibility and restriction management: assess product eligibility via ERP and regulatory system reviews, initiate restriction release requests, monitor product status reports, partner with Local Regulatory Affairs teams to fix ERP-regulatory data inconsistencies, and guide corrective actions for uninterrupted supply.
- Regulatory operations and lifecycle management: support new product introductions, product changes, discontinuations and lifecycle maintenance; maintain regulatory data in MDRIM, ERP, Health Authority databases and related systems; carry out impact assessments, regulatory actions and license maintenance.
- Documentation, tender and customer support: maintain regulatory document repositories and certificate libraries, provide certificates, licenses, declarations and product documentation to Local Regulatory Affairs teams, support tender submissions, and respond to customer and market requests.
Required profile
- Higher education degree.
- Approximately 2 years of related experience (desirable in regulatory affairs).
- Greek language.
- Process orientation and excellent interpersonal and communication skills.
Required skills
- ERP knowledge (JDE 8.12 and SAP4HANA)
- RA database knowledge (MDRiM and RAD)
What we offer
- Base pay range of EUR 26,300 to EUR 42,320.
- Annual bonus with a set target depending on pay grade and location, or sales commissions.
- Vacation days, parental leave of at least 12 weeks, bereavement and caregiver leave, volunteer leave, well-being reimbursement and health programmes.
- Service anniversary and recognition awards, and optional insurance plans for eligible employees and dependents.
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jj
Maroussi - Athens
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