Quality, Compliance and Regulatory Affairs Specialist
About the role
We are currently looking for a Quality, Compliance and Regulatory Affairs Specialist for our Health and Medical business unit in Türkiye.
The position reports to the Public and Regulatory Affairs Manager and it is based in Kartal, Istanbul office and working on a hybrid pattern which will be 3 days in the office with a flexibility to work 2 days from home.
About the company
Essity is a leading global hygiene and health company that is improving well-being and shaping a healthier future for all. With 36,000 employees and sales in 150 countries, what we do makes a difference in people’s lives, every day.
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® and TENA®, 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. Join us in breaking barriers to well-being!
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.
Establish and maintain a project chart and an authorization overview for registration and reimbursement submissions.
Provide input to support processes, as reflected in GMS (Global Management system), related to regulatory, reimbursement and compliance.
Assist commercial team in collecting and drafting relevant documentation required for the submissions to tenders,
Assist the commercial organization with MedTech compliance, run IDMP (Independent decision-making) process and fill the necessary transparency submissions to Ministry of Health regarding medical events and organizations.
Is accountable for their formal correctness of documents to be provided.
Assist in Document Control & Change Control activities in order to perform, train and cross-train other company associates.
Maintain Quality Handbook and act in lead in quality related processes related to ISO 9001, 13485, and 27001.
Maintain a Standards Library of all required standards and updated standards, as needed, and inform relevant stakeholders.
Draft, recommend and help close reports for corrective and preventive actions.
Who You are:
A “Barrier Breaker to Health and Hygiene” who is committed to reach his/her 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.
University degree in medicine, pharmacy, health sciences or biomedical engineering is preferred.
Additional knowledge on commercial aspects of the business is helpful.
+3 years of experience in the medical/pharmaceutical industry in regulatory affairs and market access, quality and/or a medical compliance function at a country level.
Advanced analytical skills to handle a range of complex relationships/issues/multiple projects simultaneously.
Excellent oral / written communications skills Turkish and English.
Absolute commitment to the highest ethical standards and accountability for individual actions
Able to travel.
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.
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