Job details
Position Summary
As a Regulatory Affairs Specialist with approximately 3 years of experience, you will support regulatory activities across the product lifecycle, ensuring compliance with local, regional, and global regulations. You will contribute to submissions, postmarket requirements, and regulatory documentation, while collaborating with cross-functional teams.
Key Responsibilities
Support the preparation and maintenance of regulatory documentation, including licenses, registrations, and product listings
Help ensure postmarket regulatory requirements are met, including compiling and submitting required reports and supplemental dossiers
Contribute to the preparation and submission of notifiable changes to regulatory authorities
Assist in reporting product safety issues in accordance with applicable regulations
Provide documentation and support for product reimbursement requests
Support regulatory input during inspections and audits
Monitor regulatory intelligence and assist in summarizing key updates for internal teams
Collaborate with cross-functional teams to support regulatory compliance throughout the product lifecycle
Assist in identifying regulatory requirements and potential obstacles for market access and distribution
Help evaluate proposed products for regulatory classification and submission pathways
Participate in the preparation of regulatory submissions and monitor review progress
Support the development and maintenance of regulatory SOPs and training materials
Communicate with regulatory authorities under guidance from senior staff
Minimum Requirements
Bachelor’s degree in Engineering, Life Sciences, or a related technical field (or equivalent combination of education and experience).
At least 3 years of experience in regulatory compliance, quality assurance, or product development within the medical device industry.
Good written and verbal communication skills in English and Swedish.
Preferred qualifications
Experience supporting medical device product development lifecycle, including Regulatory Affairs activities and contributing to global strategy and lifecycle management.
Exposure to interactions with regulatory agencies (e.g., FDA, MoH, Notified Bodies).
Contributed to complex submissions (e.g., 510(k), PMA, CE Marking) and supported regulatory audits under guidance.
Working knowledge of US and global medical device regulations (e.g., FDA, EU MDR, ISO 13485, MDSAP), with ability to apply regulatory requirements to projects.
Demonstrated organizational and project coordination skills; able to manage multiple tasks with supervision.
Commitment to product quality and compliance, with ability to identify regulatory risks.
Experience collaborating with cross-functional teams such as Product Development, Quality, and Marketing.
