Principal Regulatory Affairs Specialist

Employer Industry: Medical Device Manufacturing Why consider this job opportunity: Opportunity for career advancement and growth within the organization Competitive salary based on experience Chance to work on innovative medical devices that impact patient care Supportive and collaborative work environment Involvement in cross-functional teams and projects What to Expect (Job Responsibilities): Develop and author regulatory submissions, including Q-Submissions, 510(k), IDE, and PMAs Provide regulatory guidance to cross-functional teams and develop global regulatory strategies Prepare and submit regulatory documents for US and OUS regulatory filings Ensure compliance with quality system regulations and international product registration requirements Participate in audits and inspections and review marketing materials for compliance What is Required (Qualifications): Bachelor’s degree in chemistry, scientific, or engineering discipline 4+ years of work experience in regulatory affairs within the medical device, biotech, or pharmaceutical industry Direct experience in preparing premarket documents such as 510(k), IDE, PMA, Technical File, and Design Dossiers Excellent knowledge of global medical device regulatory requirements and product registration Strong oral and written communication skills with the ability to work in a team environment How to Stand Out (Preferred Qualifications): Regulatory Affairs Certification (RAC) Experience interfacing with FDA personnel and preparing Pre-Submissions Familiarity with product development processes and design control Ability to assess changes to marketed products and their regulatory implications Proficiency in MS Word and Excel

#J-18808-Ljbffr