Senior Regulatory Affairs Manager – Medical Devices
Location: Malmö, on-site
Company: Magle Group

Magle Group is looking for an experienced Senior Regulatory Affairs Manager to join our small but dynamic regulatory team. We support other Life Science companies by providing CDMO services while also developing and manufacturing our own products with DSM technology.

In this role, you will focus on our medical devices business, ensuring compliance with all regulatory standards and guidelines applicable in our active markets, and play a key leadership role in guiding regulatory strategy across the organization.

Key Responsibilities:

• Lead and manage regulatory strategy, submissions, and lifecycle management for our medical devices’ portfolio.
• Oversee preparation and submission of regulatory documentation for approvals and registrations in international markets, including FDA submissions and CE marking.
• Monitor regulatory developments and ensure organizational compliance; advise leadership on necessary adjustments.

• Maintain and manage regulatory files, including renewals, device listings, site registrations, supplements, and annual reports.

• Lead change control activities and assess device-related incidents and complaints for reporting to regulatory authorities; manage recalls and field actions when required.
• Review and approve product labelling and promotional materials to ensure compliance with applicable regulations.
• Assess device-related incidents and complaints for medical device reporting requirements. Compile and submit reportable events to relevant regulatory authorities in a timely manner. Handle recalls and field actions, if required
• Support clinical trial applications, ethics board submissions, and regulatory reporting for investigational device trials.
• Mentor and guide junior regulatory staff, fostering best practices and ensuring regulatory excellence across the organization.
• Serve as the main point of contact with regulatory authorities and auditors.
• Other duties as assigned to support the regulatory team and ensure compliance with global regulatory requirements.

Qualifications:

• Bachelor’s degree in a scientific or related field; advanced degree preferred.
• Minimum of 5–7 years of experience in medical device regulatory affairs, with demonstrated expertise in MDR and FDA regulations.
• Strong understanding of international regulatory guidelines and standards such as FDA, CE Marking, NBOG, ISO 13485, MDR etc.
• Experience with Class II and Class III medical devices is highly preferred.
• Excellent communication and leadership skills, capable of interacting with executive management and regulatory authorities.
• Highly organized with the ability to manage multiple high-priority projects in a fast-paced environment.

Meriting Experience:

• Experience with APIs, including CEP and ASMF files.
• Familiarity with regulatory requirements in Europe, North America, and Asia.
• Familiarity with regulatory landscape in key international markets (e.g., Europe, Asia, and North America).
• Proficient with regulatory submission software and document management systems.

Why Magle Group:
We are a value-driven organization passionate about making a global impact on patients’ lives. We are looking for someone who not only meets the qualifications but also aligns with our mission and culture.

This is a full-time, on-site position in Malmö. Recruitment will be ongoing, with the last day for applying being 31/10. Please submit your CV and a short cover letter describing why this position interests you. 

Find out more about us at: www.maglegroup.com