Global Medical Devices Regulatory Strategist

Katalyst-Healthcares-; Port Reading (NJ); On-site; USD 90,000 - 130,000; Full time

Job summary

Baxter in the United States is seeking a Regulatory Affairs professional to coordinate and prepare regulatory submission documents for medical devices. You will review technical data, support regulatory strategies, and respond to questions from authorities across US and EU markets.

Responsibilities include compiling global submissions, maintaining files, and collaborating with cross-functional teams to track status and ensure compliance with applicable regulations.

Qualifications

• Experience in medical devices regulatory affairs.
• Knowledge of U.S. and international (EU) device regulations.
• Experience developing or supporting regulatory strategies.
• Experience working with cross-functional teams.
• Experience interacting with regulatory authorities (e.g., FDA, TÜV).

Responsibilities

• Coordinate and prepare global regulatory submission documents.
• Review technical and scientific data supporting submissions.
• Support regulatory strategies and respond to questions from authorities.
• Maintain regulatory files and documentation.
• Assist with labeling, SOPs, and departmental documents.
• Track regulatory submission status and document progress.
• Edit and proofread regulatory documents.
• Participate in cross-functional project teams.
• Manage multiple regulatory projects and priorities.

Skills

Regulatory affairs

Cross-functional collaboration

Regulatory strategy development

Documentation tracking

Regulatory project management

Education

Bachelor's degree in a relevant scientific discipline

Job description

Baxter in the United States is seeking a Regulatory Affairs professional to coordinate and prepare regulatory submission documents for medical devices. You will review technical data, support regulatory strategies, and respond to questions from authorities across US and EU markets.

Responsibilities include compiling global submissions, maintaining files, and collaborating with cross-functional teams to track status and ensure compliance with applicable regulations.