Regulatory Affairs Associate – Medical Device Sweden

Resourcing Life Science; Sweden; On-site; SEK 550,000 - 850,000; Full time

Job summary

Resourcing Life Science in Sweden is seeking a Regulatory Affairs professional to manage regulatory impact assessments for product changes, oversee annual registrations and license renewals, and support the preparation, submission, and maintenance of FDA dossiers.

You will coordinate data collection for international registrations, collaborate with global Regulatory Affairs partners and cross-functional stakeholders to ensure timely, compliant submissions, and perform essential administrative

Qualifications

• Bachelor degree is required.
• Min 4 years of experience in Regulatory Affairs in the medical device field.
• Experience with global submissions, preferably including FDA.
• Excellent communication and problem-solving skills.
• Fluent in English (written and spoken).

Responsibilities

• Conduct regulatory impact assessments for product changes, including determination of letter-to-file versus submission requirements.
• Manage annual registrations, license renewals, and ongoing regulatory notifications.
• Support the preparation, submission, and maintenance of FDA dossiers and related technical documentation.
• Coordinate the collection, review, and consolidation of data for international regulatory registrations.
• Collaborate with global Regulatory Affairs partners and cross-functional stakeholders to ensure timely, compliant submissions.
• Execute administrative, documentation, and procedural activities supporting the Regulatory Affairs function.

Skills

Regulatory affairs

Communication

Problem solving

English fluency

Education

Bachelor degree

Job description

What to Expect

• Conduct regulatory impact assessments for product changes, including determination of letter-to-file versus submission requirements.
• Manage annual registrations, license renewals, and ongoing regulatory notifications.
• Support the preparation, submission, and maintenance of FDA dossiers and related technical documentation.
• Coordinate the collection, review, and consolidation of data for international regulatory registrations.
• Collaborate with global Regulatory Affairs partners and cross-functional stakeholders to ensure timely, compliant submissions.
• Execute administrative, documentation, and procedural activities supporting the Regulatory Affairs function.

Requirements

• Bachelor degree
• Min 4 years of experience in Regulatory Affairs in the medical device
• Proven experience with global submissions, preferably including FDA,
• Excellent communication and problem-solving skills
• Fluent in English (written and spoken).