Regulatory Affairs Associate

• Support regulatory and labeling activities for medical device products, ensuring compliance with global regulatory requirements.
• Lead labeling design, development, and implementation initiatives across international markets.
• Collaborate with cross-functional teams to manage labeling projects, regulatory submissions, and process improvements.
• Monitor regulatory changes and ensure alignment with internal quality systems and procedures.

Responsibilities:

• Develop and design product labeling including instructions for use, product labels, and country-specific requirements.
• Collaborate with regulatory teams and stakeholders to define labeling strategies.
• Ensure compliance with regulatory standards and international requirements.
• Manage labeling change projects and coordinate timelines and deliverables.
• Assess project scope and impact on labeling requirements.
• Prepare and submit labeling documentation and packages for approval.
• Coordinate labeling release activities with cross-functional teams.
• Troubleshoot issues and propose effective solutions.
• Monitor regulatory changes and implement updates to processes and documentation.
• Maintain accurate records of labeling changes and approvals.
• Support audits and prepare reports and dashboards for regulatory metrics.
• Drive continuous improvement initiatives within the quality system.

Skills:

• Strong knowledge of regulatory requirements for medical device labeling.
• Excellent communication and collaboration skills.
• Strong organizational and time management abilities.
• Ability to manage multiple projects simultaneously.
• Strong analytical and problem-solving skills.
• Proficiency in Microsoft Office and related tools.
• Ability to work independently and drive tasks to completion.

Experience:

• Minimum of 4 years of experience in a regulated industry.
• Experience in regulatory, quality, engineering, or related operational areas.
• Experience in labeling design and development from a regulatory perspective.

Should Have:

• Experience with international regulatory requirements and labeling.
• Experience with SAP or content management systems.
• Experience coordinating projects in a regulated environment.
• Familiarity with document management and compliance processes.

Qualification And Education:

• Bachelor s degree in Regulatory Affairs, Biomedical Engineering, or a related field required.