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Job #03621

About our client Our client is a leading biomedical company based in Ohio. They focus on the development and commercialization of surgical and diagnostic products that enhance patient care. Position Location Regulatory Affairs Manager Ohio Salary Highly competitive package, commensurate with experience Responsibilities 1) Ensure all government and international report systems and documentation comply with regulatory requirements for therapeutic, medical or diagnostic products 2) Develop content and format for domestic and foreign regulatory submissions for the company’s device, drug and biologic products 3) Advise corporate personnel regarding developing and implementing regulatory strategy, potential areas of regulatory concern and new government/regulatory developments 4) Develop content and format for INDs, BLAs, NDAs, 510(k)s, PMAs and related supplements and amendments 5) Review and approve technical data and verify accuracy of clinical data and execution of clinical projects 6) Develop, implement and review current policies and practices issued by US and international regulatory agencies 7) Serve as regulatory affairs representative on assigned teams to provide input on phase I, II and III clinical trial-filing activities and non-clinical study activities 8) Ensure that compliant reporting systems are maintained 9) Coordinate with other departments to achieve project goals 10) Review regulatory publications to keep apprised of new regulatory developments 11) Maintain quality management system and processes to ensure changes to programs, procedures and processes are approved, appropriately documented and validated 12) Work with suppliers to ensure that company and supplier facilities pass regulatory inspection(s) 13) Design and generate creative solutions and demonstrate attention to detail 14) Identify and resolve problems in a timely manner 15) Gather and analyze information skillfully 16) Develop alternative solutions, work well in group problem-solving situations and use reason even when dealing with emotional topics 17) Develop project plans, coordinate projects, communicate changes and progress 18) Complete projects on time and in budget and manage project team activities 19) Assess own strengths and weaknesses, pursue training and development opportunities and strive continuously to build knowledge and skills 20) Share expertise with others and meet commitments 21) Focus on solving conflict, not blaming, maintain confidentiality and keep emotions under control 22) Speak clearly and persuasively in positive or negative situations, listen and get clarification, respond well to questions and demonstrate group presentation skills 23) Participate in meetings 24) Write clearly and informatively, edit work for spelling and grammar, vary writing style to meet needs and present numerical data effectively 25) Display able to read and interpret written information 26) Balance team and individual responsibilities, exhibit objectivity and openness to others' views and contribute to building a positive team spirit 27) Put success of team above own interests and support everyone's efforts to succeed 28) Display passion and optimism and inspire respect and trust 29) Develop workable implementation plans, communicate changes effectively, build commitment and overcome resistance 30) Prepare and support those affected by change, monitor transition and evaluates results 31) Delegate work assignments, match the responsibility to the person, give authority to work independently and set expectation 32) Monitor delegated activities and provide recognition for results 33) Exhibit confidence in self and others, inspire and motivate others to perform well and give appropriate recognition to others 34) Include staff in planning, decision-making, facilitating and process improvement and take responsibility for subordinates' activities 35) Make self available to staff, develop subordinates' skills and encourage growth 36) Foster quality focus in others and continually work to improve supervisory skills 37) Look for ways to improve and promote quality and demonstrate accuracy and thoroughness 38) Understand business implications of decisions and demonstrate knowledge of market and competition 39) Work within approved budget, develop and implement, cost-saving measures and contribute to profits and revenue 40) Demonstrate knowledge of EEO policy and promote a harassment-free environment 41) Treat people with respect, keep commitment, inspire the trust of others and work with integrity and ethically 42) Uphold organizational values 43) Follow policies and procedure and support organization's goals and values 44) Develop strategies to achieve organizational goals and understand organization's strengths and weaknesses 45) Identify external threats and opportunities and adapt strategy to changing conditions 46) Display willingness to make decisions and exhibit sound and accurate judgment 47) Support and explain reasoning for decisions including appropriate people in decision-making process and make timely decisions 48) Demonstrate persistence, overcome obstacles and measure self against standard of excellence 49) Prioritize and plan work activities 50) Use time efficiently, plan for additional resources, set goals and objectives and organize or schedule other people and their tasks 51) Develop realistic action plans 52) Approach others in a tactful manner, react well under pressure, treat others with respect and consideration regardless of their status or position 53) Accept responsibility for own actions and follow through on commitments 54) Demonstrate accuracy and thoroughness and look for ways to improve and promote quality 55) Apply feedback to improve performance and monitor own work to ensure quality 56) Meet productivity standards, complete work in timely manner and strive to increase productivity 57) Observe safety and security procedures and use equipment safely 58) Adapt to changes in the work environment, manage competing demands, change approach or method to best fit the situation and able to deal with frequent change, delays or unexpected events 59) Attend and be punctual at work and on time 60) Arrive at meetings and appointments on time 61) Follow instructions, respond to management direction, take responsibility for own actions and keep commitments 62) Undertake self-development activities, seek increased responsibilities, look for and take advantage of opportunities 63) Ask for and offer help when needed 64) Display original thinking and creativity and meets challenges with resourcefulness 65) Generate suggestions for improving work and develop innovative approaches and ideas 66) Present ideas and information in a manner that gets others' attention Requirements 1) College degree in Biological Sciences 2) Minimum 5 – 10 years of significant regulatory experience developing biopharmaceuticals or pharmaceuticals or equivalent combination of education and experience 3) Regulatory Affairs Professional Society – Regulatory Affairs Certification (RAPS-RAC) – preferred 4) Experience in fulfilling CTD/eCTD requirements and writing/submitting FDA submissions (IND, NDA, BLA, 510k and PMA) 5) Experience in chemistry 6) Familiarity with popular business software including Microsoft Access, Word and Excel 7) Working knowledge of FDA, EMEA, ICH and ISO regulations, guidelines and industry standards, European directives for product registration and Canadian regulations for drugs and devices 8) Demonstrated knowledge of device, drug and biologic regulatory requirements associated with the US FDA and other international regulatory agencies 9) Ability to write routine reports and correspondence 10) Excellent communication, organizational and project management skills 11) Ability to speak effectively before groups of customers or employees of the organization 12) Ability to work with mathematical concepts such as probability and statistical inference and fundamentals of plane and solid geometry and trigonometry 13) Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations 14) Technical writing abilities (preferred) 15) Ability to apply common sense/understanding in order to carry out instructions furnished in written, oral or diagram form 16) Ability to deal with problems involving several concrete variables in standardized situations 17) Ability to productively and accurately apply Statistical, Database, Design, Internet, Manufacturing, Project Management, Spreadsheet and Word Processing software applications 18) Ability to read and interpret documents such as regulations, industry standards and guidance documents, product and process specifications, etc. 19) Ability to complete SOPs and work instructions per FRM-0502 and Q-Pulse quality management system application 20) Ability to use hands to finger, handle, or feet as required 21) Ability to sit frequently and occasionally to reach with hands and arms 22) Ability to safely lift and/or move up to 35 pounds unassisted 23) Specific vision abilities including close vision, distance vision, color vision, depth perception and ability to adjust focus 24) Ability to get occasionally exposed to radiation check sources or chemicals 25) Ability to complete the employee orientation, employee handbook and quality management system 26) Willingness to commit to long hours of work when necessary to reach goals 27) Willingness to travel (up to 30% of the time, or as circumstances dictate)