Regulatory Affairs and Compliance Specialist

Regulatory Affairs and Compliance Specialist

About the role

We are currently looking for a Regulatory Affairs & Compliance Specialist, Türkiye for our Health and Medical business unit.

We offer fixed term contract for maternity cover till end of June 2027.

The position reports to the Senior Regulatory Affairs and Compliance Manager MEA-WA (Middle East, Africa and West Asia) and is based in our Kartal, Istanbul office operating in a hybrid working model with three days in the office and two days working remotely.

About the company

Essity is a global, leading hygiene and health company. Every day, our products, solutions and services are used by a billion people around the world. In 2025, Essity employed approximately 36,000 people and conducted sales in approximately 150 countries worldwide.

Health & Medical is one of Essity’s three business areas. We are dedicated to empowering healthier lives, with superior and sustainable solutions to effectively manage everyday health and medical conditions like lymphedema, chronic wounds, orthopedic injuries, incontinence and more. Through our trusted global brands that include Actimove®, Cutimed®, Delta-Cast®, JOBST®, Leukoplast® Sorbact®, TENA® and many more, we are advancing MedTech and digital health innovations, serving patients and customers across comprehensive touchpoints such as hospitals, retail pharmacies, nursing homes and online channels, and continuously offering even better holistic care for healthcare systems worldwide.

What You will do:

• 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) within their regulated area and ensure that all documents and processes are in accordance with internal regulatory and quality procedures as well as applicable national laws and regulations to obtain and maintain registrations and reimbursement in Türkiye.

• 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 (local UDI-DI flow).

• 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, as reflected in GMS (Global Management system), related to regulatory, quality, reimbursement and compliance.

• Assist in Document Control & Change Control activities in order to perform, train and cross-train other company associates.

• 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), healthcare professional engagements, sponsorships, grants, educational events and transparency reporting activities in accordance with internal policies and applicable laws.

• Support due diligence, onboarding and ongoing compliance monitoring activities related to distributors, service providers and other third-party partners.

• Support the maintenance and continuous improvement of the local Quality Management System in accordance with ISO 9001, ISO 13485 and applicable corporate procedures.

• Maintain a Standards Library of all required standards and updated standards, as needed, and inform relevant stakeholders.

• Support internal and external audits, CAPA management, change control, document control and training activities. Facilitate investigation and closure of quality issues, complaints, deviations and corrective actions.   

•  Ensure the accuracy, completeness and formal compliance of all documentation prepared or submitted.

Who You are:

• A “Barrier Breaker to Health and Hygiene” who is committed to achieving their goals, who has the courage to lead, who cares for his/her internal and external business partners as well as the environmental impact of actions, who excels in collaboration.  

• 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.

• A taskmaster with advanced analytical skills to handle a range of complex relationships/ issues/ multiple projects simultaneously.

• A communication expert with excellent oral / written communications skills in Turkish and English.

• Someone with absolute commitment to the highest ethical standards and accountability for individual actions who is able to travel.

Experience with UTS, TITCK regulations and reimbursement processes is an advantage.

Proven interest or additional knowledge of commercial aspects of the business is helpful.

What We Can Offer You

At Essity, we believe everyone's learning and professional development is unique and want to empower employees to reach their full potential in a winning culture motivated by a powerful purpose.
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.

Only applications in English will be considered.

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