Regulatory Affairs Registration Specialist (d/f/m)
Description
Regulatory Affairs Registration Specialist (d/f/m)
Essity is a leading global hygiene and healthcare company. We are committed to improving the quality of life through high-quality hygiene and healthcare solutions. We sell our products and solutions in around 150 countries under many strong brands, including the global market leaders TENA and Tork, as well as well-known brands such as Jobst, Leukoplast, Libero, Libresse, Lotus, Nosotras, Saba, Tempo and Zewa.
About the Role
We are seeking an expert to join the registration team. In this role, you will manage global medical device submissions. You will collate with local and global stakeholders to ensure compliance with international and national regulations.
What You Will Do
- Develop and Implement Submission Strategies: Develop and implement submission strategies for the assigned product assortment in alignment with relevant stakeholders in non-EU markets.
- Update Product Licenses and Processes: Keep product licenses and supporting processes updated with changes during product lifecycle management and changes in relevant regulations.
- Utilize Legal Knowledge: Utilize knowledge of national and international laws, regulations, guidance documents, and standards to shape and continuously improve regulatory documentation and registration activities.
- Ensure Regulatory Adherence: Ensure regulatory adherence in non-project driven business processes such as marketing and sales, quality management, sourcing, and supply for global markets.
- Contribute to Regulatory Strategy: Contribute to the creation, implementation, and development of the regulatory strategy for global markets.
- Coordinate Communication: Coordinate communication necessary for product registrations with internal and external stakeholders, particularly regulatory authorities.
Who You Are
- Scientific or technical education/degree or equivalent professional experience (>3 years) in a regulated environment.
- Knowledge of regulatory affairs, preferably international registration requirements of medical devices.
- Proficiency in MS Office; SAP experience is an advantage
- Thorough and structured working attitude.
- Ability to effectively work collaboratively in cross-functional teams, intercultural competence.
- Fluency in written and spoken English
This Is Us
At Essity our Beliefs & Behaviours (Care, Collaboration, Courage and Commitment) is the foundation for our inclusive culture and as such something we are living on an everyday basis. With a purpose of Breaking Barriers to Well-being diversity, equity & inclusion is established in our core.
We are committed against discrimination on the basis of color, ethnicity, migration history, religion, sex, national origin, sexual orientation, age, citizenship status, marital status, caregiving responsibilities, disability, chronic illness, gender identity, gender expression, genetic information and other. We explicitly welcome applications from people who are structurally, institutionally, intersectionally discriminated.