Director of Regulatory Affairs/Quality Assurance - Stockholm - Medical Device

A Regulatory Affairs Director in Sweden working for a small company specializing in implantable medical devices plays a critical role in ensuring that the company's products comply with the regulatory requirements and standards in Sweden, the European Union (EU), and other relevant international markets.

The job description for this position includes the following responsibilities:

Your responsibilities include:

• Develop and implement regulatory strategies, staying updated on regulatory changes.

• Prepare and submit regulatory applications for new products, changes, and license renewals.

• Ensure compliance with local and EU regulations and maintain a quality management system.

• Develop and maintain risk management documentation according to ISO 14971.

• Create and maintain regulatory documents and product labeling.

• Stay informed and communicate regulatory requirements internally.

• Prepare for and respond to regulatory audits and inspections.

• Establish a system for post-market surveillance and adverse event reporting.

• Work closely with cross-functional teams throughout the product lifecycle.

• Lead a regulatory affairs team, provide training, and mentoring.

• Manage the department's budget and allocate resources effectively.

Qualifications:

• Relevant degree
• Extensive regulatory affairs experience in medical devices, especially implantable devices
• Proficiency in Swedish and EU medical device regulations
• Strong leadership, project management, and communication skills
• Ability to adapt to a dynamic small company environment
• Regulatory certifications (e.g., RAC) preferred