As a Senior Regulatory Affairs Specialist with this fast growing, Class II medical device company, you will be responsible for product submissions, license renewals, periodic updates and registrations to regulatory agencies. You will organize regulatory information and track and control submissions, review and advise on labeling for compliance with regulatory filings, review product changes for impact on regulatory filings worldwide, and research regulatory issues and provide guidance and advice to colleagues. Specific Duties and Responsibilities : *Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy *Timely compile materials for license renewals, updates and registrations *Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or partners *Review labeling and labels for compliance with regulatory requirements *Review changes to existing products and SOPs to define the requirements for regulatory submissions *Provide the regulatory reviews of customer complaints and define the regulatory reportability *Responsible for timely registration of the facility *Maintain current knowledge of FDA and international regulation, guidance and standards applicable to company products *Actively participate in evaluation of regulatory compliance of document / product / process /test methods changes *Participate in research of regulatory issues and dissemination regulatory information to Production, QA, QC and R&D departments and senior management as required. Core Job Responsibilities: • Represent Regulatory Affairs on R&D product development project teams to ensure all regulatory requirements are met throughout the development process. • Complete submissions to FDA, EU regulatory entities. • Create and maintain product EU technical files. • Review advertising and marketing material for appropriateness and compliance to regulatory requirements and laws.
Top Skills Details:
Regulatory Affairs Medical Device EU MDR
Additional Skills & Qualifications:
Requires BA degree in a science or related field • At least 1-5 years relevant experience within the regulatory affairs discipline • Knowledge of US and international medical device regulatory requirements • Experience with Class II devices is mandatory
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.