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Job #03242

About our client Our client is one of the world's leading medical device providers. They are a highly profitable, publicly traded company whose products are currently being sold in over 120 countries worldwide. This is a great opportunity for someone to join a company, which offers a great corporate culture and is focused on the long-term development of its employees. Position Location Regulatory Compliance Specialist Allendale, New Jersey Salary Highly competitive package, commensurate with experience Responsibilities 1) Evaluate the reported events for reportability to FDA under MDR regulations and submit reports within the specified timeframes 2) Coordinate product recalls in the US and complete/review associated documentation within required timeframes 3) Provide ad-hoc reports to management (as required) 4) Follow-up with sales reps and hospitals to obtain applicable information pertaining to reported events 5) Coordinate obtaining medical opinions in support of reporting and field actions 6) Obtain product function information in collaboration with engineers to determine reportability 7) Review PERs for reportability to the FDA and other competent authorities under MDR regulations 8) Ensure timely completion of MDR rationales and initial, supplemental and final incident reports to FDA and other competent authorities within specified timeframes 9) Coordinate with QA all documentation required to reach a decision regarding a field action (as required by the company’s policies/procedures) 10) Manage all activities, communication and documentation required to conduct and conclude a field action in the US 11) Ensure notification, to FDA, of reportable field actions and submission and follow-up of all required documentation 12) Liaise with other areas of the RA/QA Team in related projects and initiatives for process improvement 13) Maintain training and awareness of related US federal regulations pertaining to MDR and recall activities 14) Perform training for in-house and field personnel on PER, MDR reporting and recalls 15) Prepare ad-hoc reports of recalls, complaint and MDR trends (as required) 16) Provide MAUDE database searches and reports as required 17) Participate in special projects and perform other miscellaneous duties (as required) Requirements 1) BA/BS in Health or Science-related field and RN preferred 2) 1 – 3 years experience in the medical device industry 3) Experience in analyzing product complaints for reportability to the FDA and in managing US regulatory actions 4) Experience in coordinating with the FDA 5) Knowledge of regulatory requirements, 21 CFR, ISO 9001 and quality system regulation 6) Computer literate with knowledge of MS Office 7) Superb communication (written and oral) and interpersonal, analytical, problem-solving and troubleshooting skills 8) Ability to work in a team environment 9) Ability to work closely with engineers and other team members in understanding device functionality and surgical techniques to evaluate complaints for reportability 10) Ability to understand/explain detailed regulatory compliance programs/issues and comply with constantly changing regulatory requirements 11) Ability to multi-task and respond to the urgent needs of the team with strong track record of meeting deadlines 12) Positive, energetic team player, a quick learner as well as an advocate for product excellence and quality