Regulatory Affairs Specialist

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

Role Summary: Responsible for global coordination and preparation of regulatory submission documents/packages for Baxter medical devices. The role involves reviewing technical/scientific data, supporting regulatory strategies, preparing responses to regulatory authorities, and ensuring regulatory documentation meets applicable requirements across the U.S. and international markets, especially EU regulations.

Key Responsibilities:

• Support execution of regulatory project plans.
• Compile and prepare global regulatory submissions.
• Review technical and scientific data supporting submissions.
• Prepare responses to questions from regulatory authorities.
• Maintain regulatory files and documentation.
• Assist with labeling, SOPs, and departmental documents.
• Track regulatory submission/documentation status.
• Edit and proofread regulatory documents.
• Participate in cross-functional project teams.
• Manage multiple regulatory projects and priorities.

Must-Haves:

• Experience with medical devices / healthcare regulatory affairs.
• Knowledge of U.S. and OUS device regulations, especially EU regulations.
• Experience developing or supporting Regulatory Affairs strategies.
• Experience working with cross-functional teams.
• Experience interacting with external regulatory authorities, such as FDA and TÜV.
• Bachelor's degree in a relevant scientific discipline or equivalent experience.