We are looking for a
(Senior) Regulatory Affairs Manager
for our Professional Hygiene business area
About the position
In this role, you will be in charge of managing regulatory activities related to ISO 13485 and MDR class I and II products, and you will ensure compliance with European regulations. You will be managing regulatory submissions, maintaining up-to-date knowledge of regulatory requirements, and ensuring that all products meet the necessary safety and effectiveness standards. You will work closely with cross-functional teams to support product development and market access. Depending on your profile, we can adjust the responsibilities of the role.
You will work internationally in close collaboration with Kiilto’s global QA and regulatory specialists at other locations in Nordic countries, and with other key stakeholders, applying best practices. The location of this position is in Turku, but some travel will be required. Although Kiilto follows a hybrid working model, the work requires a regular onsite presence.
Main responsibilities
- Ensure compliance with the EU MDR (Medical Device Regulation) for Class I and Class II medical devices
- Prepare, approve, and submit technical documentation for product approvals
- Maintain technical documentation, and ensure timely renewals and updates
- Act in a PRRC (person responsible for regulatory compliance) role concerning technical documentation and the EU declaration of conformity
- Interact with regulatory authorities to facilitate product approvals and address queries
- Monitor changes in regulations, and communicate updates to relevant teams
- Collaborate with product development, quality assurance, and business development to ensure regulatory requirements are met
- Provide regulatory guidance and training to internal teams
Suitable professional background
- Master’s degree in life sciences or technology
- Minimum three years’ experience in regulatory affairs, preferably in the medical device industry
- In-depth knowledge of the EU MDR and applicable standards (e.g. ISO 13485, ISO 14971)
- Knowledge of biocidal regulation is considered an asset
- Proficiency in Finnish and English languages; Swedish is a plus
- Excellent communication and collaborative skills
- Project management skills
- Know-how in statistical methods
At Kiilto, you will be working with a growing and international, but down-to-earth family business. Kiiltonians appreciate our long-term perspective, open and transparent company culture, the Kiiltonian team spirit and versatile opportunities to acquire new skills and grow alongside the company. We organize internal innovation programs and encourage Kiiltonians to develop their skills through our own training programs. We are especially proud of our award-winning activities that promote the well-being of our employees. For example, we have been awarded the 'Finland's Most Active Workplace' certificate twice.
Do you want to be part of our community? Do not hesitate to apply. The last day to apply is 11 May 2025. Please apply here and attach your salary request and CV.
For further details on the position, please contact RDI Director Oili Kallatsa, +358-50-5769243 on 28 April between 16.00 and 17.30 EET or on 6 May between 9.00 and 10.00 EET.
We operate in compliance with Kiilto’s recruitment process and treat all communications related to the posting with absolute confidentiality. We will send video interview questions to selected applicants. We also ask that applicants reserve 23 May as a possible interview date, but please note that we might contact and meet potential candidates during the application period. The selected candidate will need to pass a health check, which includes drug testing.
KiiltoClean Oy is part of Kiilto, a family-owned company based in Finland with over a hundred years of history and a vision looking ahead to 2080. We develop, produce and market chemical industry solutions in the fields of construction, industrial adhesives and fireproofing, professional hygiene and consumer goods. The key principles underlying our operations are environmental leadership, closeness and commitment to the future. Kiilto operates in nine countries and employs a total of over 700 people. In 2024, the group's net sales amounted to 220 M€. www.kiilto.com