Regulatory Affairs and Compliance Specialist

Essity

Regulatory Affairs & Compliance Specialist managing medical device regulatory documentation in Turkey. Collaborating across teams to ensure compliance and support market authorization.

Posted 7/2/2026full-timeIstanbul • 🇹🇷 TurkeyMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory affairs and market access within the medical industry, with a strong focus on compliance, documentation management, and stakeholder communication. Proficient in navigating healthcare regulations and maintaining product records in regulatory systems.

Highest-signal resume keywords

Regulatory AffairsHealthcare ComplianceProject ManagementStakeholder ManagementMedical Device Regulations

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory IntelligenceDocument ControlChange ControlMarket AuthorizationReimbursement ProcessesProduct TraceabilityQuality ProceduresTechnical DocumentationHealthcare RegulationsDigital Proficiency

Soft Skills

Communication SkillsInterpersonal SkillsCollaboration

Tools & Technologies

Microsoft 365Document Management SystemsUTSLocal Regulatory Databases

Industry Keywords

Medical DeviceCosmeticsEconomic Operator ObligationsPost-Market Regulatory ObligationsIndependent Decision Making Process (IDMP)

About the role

Key responsibilities & impact

Compile and collate documentation and technical product files necessary for the market authorization, registration and reimbursement of the assigned product assortment (Medical Device and Cosmetics).
Ensure that all documents and processes are in accordance with internal regulatory and quality procedures as well as applicable national laws and regulations.
Maintain product records and regulatory information in applicable Ministry of Health systems, including UTS and other regulatory platforms.
Support compliance activities associated with Economic Operator obligations, product traceability requirements and post-market regulatory obligations.
Establish and maintain a project chart and an authorization overview for registration and reimbursement submissions.
Monitor changes in healthcare, medical device and reimbursement regulations and communicate impacts to relevant stakeholders.
Provide input to support processes related to regulatory, quality, reimbursement and compliance.
Assist in Document Control & Change Control activities.
Support the commercial team in collecting and preparing documentation required for tender submissions.
Support and facilitate healthcare compliance reviews, including Independent Decision Making Process (IDMP).

Requirements

What you’ll need

A University graduate, who holds a degree in biology, molecular biology & genetics, chemistry, chemical engineering, medicine, pharmacy, health sciences or biomedical engineering.
Knowledgeable in healthcare compliance, medical device regulations and regulatory intelligence, with project management and stakeholder management skills.
Digital-savvy, with proficiency in Microsoft 365, document management systems and local regulatory databases.
A professional with 3-5 years of experience in the medical industry in regulatory affairs and market access, quality and/or a healthcare compliance function at a country level.
Experience with UTS, TITCK regulations and reimbursement processes is an advantage.
Communication expert with excellent oral / written communications skills in Turkish and English.

Benefits

Comp & perks

Collaborative and Inclusive Culture
Empowering & Engaged Leaders
Working with Powerful Purpose & Sustainable Impact
Learning and Growing in your Career
Supporting Well-being & Sustainable Working Life
Life-changing Innovations
Competitive Total rewards