Regulatory Affairs Specialist, Medical Devices

Job title:

Regulatory Affairs Specialist, Medical Devices

Company

Karo Healthcare

Job description

Karo Healthcare, a dynamic and growing personal-care retail company, is all about making smart choices for everyday healthcare. With a wide-ranging portfolio across seven categories including medical products, we own and sell over 80 brands in about 90 countries. Our portfolio includes such brands as E45, Pevaryl, Lamisil, Nutravita, Decubal and many others. Our core belief in empowering people to make intelligent health decisions drives our growth strategy, blending organic expansion and M&A.
Join us at Karo Healthcare on our exciting journey. We’re currently looking for a Regulatory Affairs Specialist, Medical Device for our office in Stockholm.What’s in it for you?Step into a high-impact role with global reach. At Karo, you’ll be part of an agile, fast-moving international business where you can grow your career through hands-on involvement, cross-functional collaboration, and opportunities for development in a highly entrepreneurial environment.What you’ll be doingAs our Regulatory Affairs Specialist, you’ll play a key role in ensuring our medical devices meet global regulatory standards. You’ll drive compliance, support commercial strategies, and contribute to Karo’s continued international growth.Your core responsibilities will include:

• Maintain oversight of regulatory activities for a defined product portfolio
• Contribute to regulatory strategy and lifecycle management of medical device dossiers
• Manage technical files according to ISO 13485 and relevant regulations
• Maintain and update technical documentation for a global portfolio of medical devices
• Support team members by updating documents, preparing templates, and reviewing materials based on internal instructions

• Collaborate with distributors to support international registrations by providing required documentation
• Participate in regular product lifecycle tasks, audits, and quality updates
• Help maintain strong communication and coordination across internal teams and external partners

• Review product artwork and marketing materials from a compliance standpoint

RequirementsWhat you’ll bringWe’re looking for someone hands-on, proactive, and energized by working in a collaborative, fast-paced setting – especially with a global scope.

• University degree in Engineering or Natural Sciences
• 1–2 years’ experience in Regulatory Affairs, ideally within life sciences or FMCG-like environments
• Solid understanding of technical documentation and relevant regulatory standards (MDD/MDR, ISO 13485, ISO 14971)
• Strong communication skills and ability to collaborate efficient with internal and external stakeholders
• Excellent organizational skills with attention to detail
• Fluent in English (additional languages a plus)
• Comfortable navigating change, prioritizing workload, and acting with a solution-driven mindset

Benefits

• Opportunity to create, grow, and encourage
• Apart from a competitive salary pack, there are lots of growth opportunities to meet your personal ambitions
• Flexible schedule, hybrid model with the primary work place in the office, and life-work balance
• Responsibility for exciting and challenging projects that have a direct, visible impact on our customers and the industry
• Very positive work environment in a dynamic, international, and motivated team
• Start-up spirit while being a part of the large international organization with strong values

Karo Healthcare has a Diverse & Inclusive environment. We are looking for qualified candidates irrespective of gender, gender identity, sexual orientation, ethnicity, race, religion, national origin, disability or age.

Expected salary

Location

Stockholm

Job date

Fri, 25 Apr 2025 22:27:58 GMT

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