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Job #03379

About our client Our client is a global medical device company with operations in over 60 countries. They have a leadership position in their targeted markets and have established a reputation for having the dynamic environment and innovation focus of a small company, with the resources and brand presence of a large company. This is a great opportunity for the right candidate! Position Location Regulatory Affairs Project Manager New Jersey Salary Highly competitive package, commensurate with experience Responsibilities 1) Develop/implement efficient and effective regulatory strategies to bring products to the market (domestic and/or international) 2) Ensure that all strategies comply with relevant regulations and standards including design controls for the market it is intended for 3) Compile and prepare documentation to support domestic/international assigned projects including regulatory submissions 510ks, PMAs, annual reports, IDEs, HDEs, device listings, design dossiers, international/state licenses, etc. 4) Review/approve labeling, marketing and sales advertising/promotional materials 5) Ensure all regulatory documents are complete and accurate 6) Review and approve engineering change orders (ECOs) through the agile system 7) Keep abreast of domestic/international regulatory requirements and standards 8) Review the design history file to ensure regulatory compliance prior to product launch 9) Maintain positive relationships with US/international government agencies and notified bodies 10) Ensure all communications with US/international government agencies and notified bodies are documented as well as available for future reference 11) Prepare departmental procedures as directed by the management 12) Participate in special projects as directed by the management 13) Supervise lower level RA associates and/or specialists (as required) Requirements 1) BA (4 year) from a college/university (Regulatory Affairs Certification preferred) 2) 5 years of regulatory experience in the medical device industry and/or related experience or training (or equivalent combination of education/experience) 3) Experience of working directly with FDA on 510(k)s and PMAs 4) Excellent problem-solving and management skills 5) Ability to work in a team