Mgr, Regulatory Affairs

CareDx, Inc. is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers products, testing services, and digital healthcare solutions along the pre- and post-transplant patient journey, and is the leading provider of genomics-based information for transplant patients.

As a Regulatory Affairs Manager in our In-Vitro Diagnostics industry, you will be responsible for planning and execution of product registrations world-wide and for maintenance of product compliance with applicable regulations and standards. In this role, you will be responsible for maintaining and assessing the international market’s regulatory framework and the regulatory activity planning for any new or changed products, market segments, or local regulations, in accordance with the company’s regulatory plan.

Minimum Qualifications:

• Bachelor's degree in a scientific discipline, engineering, or related field.
• Experience from working in a regulated medical device or pharma environment (minimum 4 years) with at least 4 years in a Regulatory Affairs role
• Experience with international regulatory submissions
• Experience in developing and maintaining regulatory compliance documentation, including technical files, regulatory dossiers, and other relevant documentation.
• Strong project management skills and the ability to prioritize and manage multiple projects simultaneously.
• Excellent communication and organizational skills
• Ability to work independently and as part of a team
• Experience with regulatory compliance audits

Preferred Qualifications:

• Master's degree in a scientific discipline, engineering, or related field.
• Experience with IVDD, IVDR, ISO 13485:2016, MDSAP
• Proficient in using regulatory software applications to track and manage regulatory submissions and documents.

Responsibilities:

• Prepare regulatory documentation for global registration
• Track and analyze regulatory changes and communicate their impact to relevant stakeholders
• Ensure compliance with all relevant regulations and guidelines
• Collaborate with cross-functional teams to develop regulatory strategies
• Provide regulatory guidance to internal teams
• Manage and maintain the regulatory archives and Regulatory Affairs Management System.

Skills:

As a Regulatory Affairs Manager, you will use your organizational and project management skills to manage global regulatory submissions and track regulatory changes. You will also communicate with external partners and internal teams to develop and implement regulatory strategies. Additionally, you will collaborate with cross-functional teams to ensure compliance and provide regulatory guidance.

This role requires strong attention to detail, strong communication skills, and a deep understanding of regulatory processes and requirements.

Language:

Excellent communication skills in both oral and written English.

General:

The position is located at the CareDx office in Stockholm or remote in Europe, travel may be required.