Not specified; eligible for annual bonus; compensa...
Fully remote
5+ years regulatory experience in medical device industry
Knowledge of fda and regulatory authorities premarket activities
Experience with risk management plans and hazard analysis
The Senior Regulatory Affairs Program Specialist acts as a technical liaison between cross-functional departments and the Regulatory Affairs team to ensure compliance
Job Summary
The Senior Regulatory Affairs Program Specialist acts as a technical liaison between cross-functional departments and the Regulatory Affairs team to ensure compliance.
ZOLL is a fast-growing company operating in over 140 countries with a culture that values innovation, self-motivation, and an entrepreneurial spirit.
This position offers eligibility for an annual bonus and comprehensive benefits plans while contributing to lifesaving technologies globally.
Matching Summary
The Senior Regulatory Affairs Program Specialist acts as a technical liaison between cross-functional departments and the Regulatory Affairs team to ensure compliance.
Salary
Not specified; Eligible for annual bonus; Compensation complies with federal, state, and local wage laws
Skills & Requirements
Must-have
5+ years regulatory experience in Medical Device Industry
Knowledge of FDA and regulatory authorities premarket activities
Experience with risk management plans and hazard analysis
Understanding of manufacturing change control processes
Ability to work under pressure to meet reporting time frames
Nice-to-have
Leadership skills in team settings
Superior interpersonal and communication skills
Proven analytical abilities for problem-solving
Entrepreneurial spirit and self-motivation
Commitment to improving patient outcomes
Key Requirements
Bachelor's Degree required
5+ years of regulatory experience in the Medical Device Industry
Previous experience working with Regulatory Authorities relative to premarket and compliance activities