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Full-time
bachelor degree
Posted 4d ago
Apply by Aug 24
~40 hrs/week
Responsibilities
The Regulatory Affairs Specialist will ensure product quality and regulatory compliance across North East and South East Asia. They will manage product registrations, lead audits, and act as a key partner for internal teams and regional distributors.
Requirements
Candidates must hold a bachelor's degree in a medical or technical field and possess at least 2 years of experience in QA/RA roles within the medical device or pharmaceutical industry. Proficiency in QMS standards and regional regulatory frameworks is essential.
Full job description
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 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!
You will play a key role in ensuring Essity's 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.
We're seeking a detail-oriented and proactive Quality & Regulatory Affairs professional who is passionate about ensuring product quality, regulatory compliance, and continuous improvement. You bring a solid foundation in quality assurance and regulatory affairs within the medical device, healthcare, or pharmaceutical industry, along with the ability to collaborate effectively across cultures and functions in a regional environment.
Bachelor’s 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.)
What We Can Offer You
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, you'll feel valued, empowered to grow, and challenged to achieve business results in a collaborative and open atmosphere. Innovate for Good | Excel Together | Be You with Us
Essity - a globally leading hygiene and health company. Our expertise in hygiene and health began with the acquisition of the Swedish company Mölnlycke in 1975, through which our roots stretch back to 1849. Today, our sustainable innovations from globally trusted brands, designed for everybody and every body, care for the well-being of 1 billion people in 150 countries every day.
Working at Essity is not just a career but a chance to make the world healthier, safer, and more hygienic. Our barrier breakers innovate for good and contribute to shaping a sustainable future. At Essity, every career is as unique as the individual. We empower employees to excel together and reach their full potential in a winning culture motivated by a powerful purpose. We provide a sustainable work-life based on flexibility for both employees and employers. At Essity, we are committed to Diversity, Equity, and Inclusion in everything we do. It is the key to our success in creating an inclusive, collaborative, and caring company culture where you can be you with us. Our purpose of Breaking Barriers to Well-being, is to enable customers and consumers to lead fuller lives at all stages of life.
Our leading global brands TENA and Tork, and other strong brands such as Actimove, Cutimed, JOBST, Knix, Leukoplast, Libero, Libresse, Lotus, Modibodi, Nosotras, Saba, Tempo, TOM Organic and Zewa. In 2025, Essity had net sales of approximately SEK 138bn (EUR 13bn) and employed 36,000 people. The company’s headquarters is located in Stockholm, Sweden and Essity is listed on Nasdaq Stockholm.If you want to join a company where dedication to people is powered by innovation, welcome to Essity!
Offices: Klarabergsviadukten 63, Stockholm, SE · Molndals bro, Molndal, Vastra Gotaland County 431 30, SE · Sandhofer Strasse 180, Mannheim, BW 68307, DE · 151 Boulevard Victor Hugo, Saint-Ouen, IdF 93400, FR · 2929 Arch St, Philadelphia, PA 19104, US
personal carebaby careIncontinence CareFeminine Caremedical solutionsBaby DiapersAway from Home TissueConsumer Tissueand MedtechConsumer Goods
Essity - a globally leading hygiene and health company. Our expertise in hygiene and health began with the acquisition of the Swedish company Mölnlycke in 1975, through which our roots stretch back to 1849. Today, our sustainable innovations from globally trusted brands, designed for everybody and every body, care for the well-being of 1 billion people in 150 countries every day.
Working at Essity is not just a career but a chance to make the world healthier, safer, and more hygienic. Our barrier breakers innovate for good and contribute to shaping a sustainable future. At Essity, every career is as unique as the individual. We empower employees to excel together and reach their full potential in a winning culture motivated by a powerful purpose. We provide a sustainable work-life based on flexibility for both employees and employers. At Essity, we are committed to Diversity, Equity, and Inclusion in everything we do. It is the key to our success in creating an inclusive, collaborative, and caring company culture where you can be you with us. Our purpose of Breaking Barriers to Well-being, is to enable customers and consumers to lead fuller lives at all stages of life.
Our leading global brands TENA and Tork, and other strong brands such as Actimove, Cutimed, JOBST, Knix, Leukoplast, Libero, Libresse, Lotus, Modibodi, Nosotras, Saba, Tempo, TOM Organic and Zewa. In 2025, Essity had net sales of approximately SEK 138bn (EUR 13bn) and employed 36,000 people. The company’s headquarters is located in Stockholm, Sweden and Essity is listed on Nasdaq Stockholm.If you want to join a company where dedication to people is powered by innovation, welcome to Essity!
Offices: Klarabergsviadukten 63, Stockholm, SE · Molndals bro, Molndal, Vastra Gotaland County 431 30, SE · Sandhofer Strasse 180, Mannheim, BW 68307, DE · 151 Boulevard Victor Hugo, Saint-Ouen, IdF 93400, FR · 2929 Arch St, Philadelphia, PA 19104, US
personal carebaby careIncontinence CareFeminine Caremedical solutionsBaby DiapersAway from Home TissueConsumer Tissueand MedtechConsumer Goods