Regulatory Affairs Specialist

Katalyst CRO is seeking a Regulatory Affairs Specialist to support Baxter medical device regulatory activities. The role coordinates and prepares global submissions, reviews technical and scientific data, supports regulatory strategies, responds to regulatory authorities, and maintains documentation for U.S. and international markets, particularly the EU.

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

Benefits

Remote work arrangement

Company

Contract research, regulatory, and validation services for life sciences

South Plainfield, New Jersey, USA

http://katalysthls.com/

51-200 employees

Qualifications

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

Required skills

Medical Device Regulatory Affairs, U.S. and EU Medical Device Regulations, Regulatory Affairs Strategy, Regulatory Authority Liaison FDA, Regulatory Authority Liaison TÜV

Experience

Mid level