Regulatory Specialist
Boule Medical AB · Stockholms län, SE
Were looking for a Regulatory Affairs professional who enjoys working close to the business, not just documenting it. At Boule, QA/RA plays an important role...
Job description
Were looking for a Regulatory Affairs professional who enjoys working close to the business, not just documenting it. At Boule, QA/RA plays an important role in supporting the organization, helping balance compliance with speed, enabling informed decisions, and contributing to sustainable growth. This role combines Regulatory Affairs with a strong QA perspective, contributing to an efficient and risk-based QMS and enabling sound decision-making across the organisation. Youll be expected to translate requirements into workable solutions, navigate complexity, and help the organisation move forward in a compliant and practical way. What youll do Drive regulatory activities across markets for our instruments and reagents (human and veterinary) Contribute to regulatory strategies and product lifecycle management Support and provide documentation for global registrations via distributors and partners Work closely with R&D, Operations, and Commercial teams Interface with Notified Bodies and regulatory authorities regarding submissions, substantial system changes, and new product developments Review design dossiers, technical documentation, and labeling to support regulatory approvals Stay...