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Job #02782

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 an established reputation for having 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 Clinical Affairs Manager Indiana Salary Highly competitive package, commensurate with experience Responsibilities 1) Handle pre-market and post-market submissions, including preparation of IDEs and corresponding PMAs 2) Ensure company compliance with FDA regulatory requirements for clinical studies 3) Manage clinical trials and supervise regulatory specialists 4) Create and submit pre-market submissions (IDEs, PMAs and related supplements/amendments) 5) Develop and implement procedures for Clinical Department 6) Manage implementation of studies and ongoing study activities 7) Ensure proper monitoring of studies 8) Train employees on internal procedures 9) Ensure maintenance of data and record keeping 10) Support the company during inspections/audits by the FDA, notified bodies or other international regulatory bodies 11) Supervise employees directly and carry out supervisory tasks as per organization's policies and applicable laws 12) Interview, hire and train employees 13) Plan, assign and direct work 14) Appraise performance as well as reward and discipline employees 15) Address complaints and resolve problems Requirements 1) Bachelor’s degree in Engineering, Biological/Life Sciences, or Nursing (Master’s degree preferred) 2) 2 years of clinical/regulatory experience 3) Knowledge of medical devices or biologics and statistics preferred 4) AS/400 experience a plus 5) In-depth knowledge of FDA and regulations (interpretation and monitoring) 6) Ability to understand and define problems, collect data, establish facts and draw valid conclusions 7) Ability to read, analyze and interpret common scientific and technical journals, financial reports as well as legal documents 8) Ability to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community 9) Ability to effectively present information to top management and team members 10) Ability to apply mathematical operations to such tasks as frequency distribution, analysis of variance, correlation techniques and factor analysis 11) Excellent computer skills (MS Excel and Word) 12) Willingness to travel