Regulatory Affairs Specialist CEA

Essity is a leading global hygiene and health company that is improving well-being and shaping a healthier future for all. With 36000 employees and sales in 150 countries what we do makes a difference in peoples lives every day.

Health & Medical is one of Essitys 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!

You will play a key role in ensuring Essitys products meet the highest quality and regulatory standards across North East and South East Asia. Acting as a trusted partner to internal teams and regional distributors you will drive complaint management quality improvement initiatives regulatory compliance and product registration activities. You will monitor evolving regulatory requirements support market access and product supply continuity lead audits and risk assessments and provide expert guidance on quality packaging labelling and compliance matters. Through close collaboration with Sales Marketing Supply Chain and external stakeholders you will help safeguard product quality patient and consumer trust and business success across the region.

• Bachelors degree in Pharmacy Biology Engineering or related medical/technical field.
• Training in Quality Assurance or Regulatory Affairs preferred.
• At least 2 years in QA/RA roles in medical devices or pharmaceuticals.
• Handling CAPA (Corrective and Preventive Actions) risk assessments and complaint management.
• Experience in product registration licensing and audits.
• Familiarity with ISO 13485 Quality Management Systems ISO 9001 or any related QMS
• GMP and GDP compliance knowledge
• Familiarity with Philippines FDA and regional regulatory frameworks (PMDA Japan MFDS Korea TFDA Taiwan NMPA China HSA Singapore Thai FDA etc.)

Our purpose Breaking Barriers to Well-Being provides meaning to everything we do. Join us to improve well-being for people and drive positive change for society and the environment. At Essity youll feel valued empowered to grow and challenged to achieve business results in a collaborative and open atmosphere. Innovate for GoodExcel Together Be You with Us