Regulatory Affairs Specialist

div.content { background: #6c6f70 } div.joqReqDescription { background: #FFF repeat-y; !important; font family: arial; !important text-align: left; color: #000; width: 900px !important; margin: 0 auto !important; position: relative; -webkit-column-count: 1; -moz-column-count: 1; padding-top: 489px; padding-left: inherit; padding-bottom: 50px; } div.joqReqDescription strong{ font family: arial; font-size: 14px; color: #000; } div.joqReqDescription p{ font family: arial; padding-left:0px; width: 892px; } div.joqReqDescription div.image-box { width: 900px; text-align: center; display: block; top: 0px; left: 5px; position: absolute; height: 150px; } div.joqReqDescription div.header-box { background-color: #00b0ca; position: absolute; top: 389px; display: block; font-family: arial !important; font-size: 30px; color: rgb(255, 255, 255); font-weight: bold; width: 883px; left: 5px; height: 72px; padding-left: 17px; padding-top: 15px; } Coloplast develops products and services that make life easier for people with very personal and private medical conditions. In Coloplast Business Centre we are responsible for global financial operations, orders administration, P&C, IT, Legal support, marketing & data analysis activities, and many others. If you have the right profile and the right amount of curiosity and ambition you can be a part of this exciting challenge. Curiosity works here! About the department The role is within the Regulatory Affairs function, a team responsible for ensuring new products are brought to market on time while meeting all applicable regulations. The team collaborates across functions to support product strategies, global compliance, and lifecycle management. About the job Do you thrive in a fast-paced, global environment where your regulatory expertise makes a real impact? As a Regulatory Affairs Specialist, you will serve as the global regulatory lead for assigned products, ensuring EU and worldwide compliance by translating complex regulatory requirements into actionable plans. You will collaborate closely with cross-functional teams, including subject matter experts and international counterparts. Your responsibilities Craft global regulatory strategies and manage end-to-end deliverables and submissions for new product introductions, regulatory maintenance, and product changes. Represent the function for assigned projects by translating regulatory requirements into clear product requirements and compliance activities. Assess and ensure the state-of-the-art compliance of labeling, technical, and clinical documentation in collaboration with experts. Evaluate global product claims and review advertising materials to ensure regulatory compliance. Assist with import/export and trade compliance activities, supporting commercial requests and good sales practices. Support post-market surveillance activities and maintain internal/external regulatory databases. Monitor and analyze emerging regulatory intelligence to inform strategy and compliance practices. Participate in the development, maintenance, and implementation of regulatory procedures and systems. Contribute to the preparation and execution of audits and inspections. Support cross-functional teams in prioritizing tasks and mitigating regulatory risks.

Requirements

Minimum Bachelor’s degree or equivalent relevant work experience. Minimum 2 years of direct regulatory affairs experience in the medical device industry or similarly regulated sectors. Preferred: Master of Science degree in regulatory science, life science, biomedical engineering, or related field. Preferred: Regulatory Affairs Certification (RAC) from RAPS or an equivalent certification. Strong cross-functional skills with a business and value chain understanding, self-management, decision-making, and critical thinking. Experience with quality management systems, design control, and validation processes. Competences Proven ability to translate complex regulatory requirements into actionable compliance strategies. Excellent collaboration and communication skills. Functional alignment and strong cross-functional partnerships with key stakeholders Strong analytical and decision-making abilities related to quality management and regulatory compliance. Master in direct regulatory environment to developing strategies and tactical plans that articulate compliance requirements with business/project objectives. Critical input provision on regulatory risks, gaps and opportunities for decision-making and development of pragmatic mitigation plans. Prioritization of assigned tasks/projects and navigate through matrix-based organizations and processes relevant to the function effectively. We offer

• Employment contract with 3-month-long probationary period
• Hybrid and onsite work from our office in Szczecin / Remote work possibilities (from Poland)
• Flexible working hours, Mon-Fri
• International work environment with Scandinavian culture
• Opportunity to use and develop foreign languages in daily work
• Fantastic work atmosphere full of respect and partnership
• Internal trainings available in CPBC Academy
• Great company events
• Sports card
• Private medical care
• Restaurant card
• Holiday bonus and occasional cards

That's not all! We have even more for you:

• Modern workplace
• No dress code zone
• Delicious coffee and fresh fruits
• Transportation co-funding

Recruitment details Please apply online with your CV in English. We will review all applications continuously and invite selected candidates further to the recruitment process. We will close the offer down once we find the best match to the role. Internal Candidates Internal candidates are responsible for informing direct manager of their involvement in the process (not later than before 1st formal interview). Before applying please see more information Internal Recruitment Policy. Thank you! #LI-Onsite #LI-Hybrid #LI-Remote Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16.000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things. Coloplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfil their potential and have a strong sense of belonging because – and not despite – of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief or physical ability. Visit us on Coloplast.com. Watch the film. Follow us on LinkedIn. 61514 #LI-CO Apply To This Job