Job Title : Regulatory Affairs Specialist

Location : Minneapolis, MN

Visa : Any (except OPT)

Purpose of the Role:

The Regulatory Affairs Specialist will play a crucial role in ensuring regulatory compliance across a wide range of medical devices. This position will support the regulatory affairs team in the preparation, submission, and management of regulatory documents, ensuring adherence to relevant global regulations and standards. The role involves strategic planning and execution to align with the company’s regulatory goals and timelines.

Scope of the Role:

This position operates within the global regulatory framework, coordinating activities across multiple regions. The Regulatory Affairs Specialist will collaborate with cross-functional teams and external regulatory bodies, ensuring that all regulatory requirements are met efficiently. This role does not involve team management responsibilities but requires strong independent project management skills.

Main Responsibilities:

• Regulatory Submissions : Prepare and submit regulatory documents to agencies such as the FDA, EMA, and other global regulatory bodies.
• Regulatory Compliance : Ensure that all products comply with relevant regulations including FDA 21 CFR 820, ISO 13485, and CE marking requirements.
• Risk Management : Conduct risk assessments and develop strategies to mitigate potential regulatory risks.
• Quality Management System (QMS) : Support the ongoing maintenance and improvement of the QMS to ensure regulatory compliance.
• Clinical Trials : Oversee the regulatory aspects of clinical trials to ensure compliance with applicable regulations.
• Post-Market Surveillance : Monitor and report on the safety and effectiveness of medical devices after they are released to the market.
• Regulatory Strategy : Develop and implement regulatory strategies to support product development and market access.
• Document Control : Manage regulatory documentation to ensure accuracy, completeness, and compliance.
• Regulatory Inspections : Prepare for and manage regulatory inspections and audits.
• Global Regulatory Compliance : Ensure adherence to international regulatory requirements and standards.

Education:

• Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related field.

Experience:

• Minimum of 3-5 years of experience in regulatory affairs within the medical device industry.

Competencies:

• Strong understanding of FDA 21 CFR 820, ISO 13485, CE marking, and global regulatory requirements.
• Excellent problem-solving, communication, and project management skills.
• Ability to manage multiple tasks simultaneously while maintaining attention to detail.
• Initiative and the ability to prioritize tasks effectively in a fast-paced environment.
• Certifications (e.g., Regulatory Affairs Certification (RAC)) are a plus.