Medical Device News and Careers
Referrals!
In the spirit of creating a fun environment and building on our existing network, we will pay a referral (or finders) fee to anyone who refers a candidate for a specific position and that candidate is ultimately placed by NCompass.
Got Jobs?
We are always looking for new business and emerging Medical Device companies that need assistance building out their teams. If you know of any companies that are currently hiring or any hiring managers that are having trouble finding top notch talent please contact us so we help! We are offering substantial finder’s fees for any new jobs that are referred to us that result in either new client contracts or closed business.
Please contact Dan or David for specifics.
You are here:
home
>
Job Details
Back to search
Director of CA/RA
| PostId | e0e36a3b-db48-4215-afe7-eb4f8a304cd9 |
| Posted Date: | 5/28/2010 |
| Job Category: | Clinical Director |
| Salary Range: | DOE |
| Location: | Bay Area (South Bay) |
| Description: | Position Title: Director of RA/CA Reports To: VP of QA/RA Location: South Bay Company: Public General Summary: Directs clinical trials activities for our medical device products. Able to execute parallel clinical trials in accordance with Good Clinical Practices and FDA or other regulations. Uses depth and breadth of experience and knowledge of cardiovascular medicine as well as a relationship network to advance successful medical devices to market. Manages the Regulatory Affairs function, encompassing all aspects of managing the interface to FDA and other regulatory bodies for a Class III medical device, particularly extensive experience with IDE & PMA submissions and approvals. Establishes project plans and translates into schedules; manages the approval, direction, planning, execution, and interpretation. Essential Functions: • Executes clinical affairs and regulatory affairs activities in accordance with the company’s strategic goals and objectives. • Able to critically assess, develop and execute successful clinical trial programs. Able to simultaneously balance multiple business, clinical, product and physician requirements. • Primary interface to FDA and other regulatory agencies (Health Canada, EU Notified Body) and regulatory consultants. • Extensive experience with IDE & PMA submissions and approvals • Manages the development of regulatory strategy. Prepares regulatory submissions. Manages communication to regulatory bodies. • Maintain all regulatory file documentation, manufacturing licenses and required agency reporting. • Ensures clinical trial compliance with regulatory requirements • Creates immediate- to long-range plans to carry out objectives for new and ongoing clinical trial research in support of regulatory submissions deadlines • Works with other department to choose investigators and clinical sites, prepare investigators meetings and training • Oversees proper collection of data and the data collection system. Manages ongoing analysis and synthesis of collected data. Analyzes data and prepare documentation for submission to obtain clearance/approval for legal market distribution of medical devices • Manages the preparation of technical and scientific publications • Analyzes activities, costs, operations, and forecast data to determine departments’ progress toward stated goals and objectives. Makes appropriate adjustments as required to better facilitate the implementation of company business strategy. • Able to brief management or customers on trial results or status • Able to interact with equivalent level intra- and inter-organizational management • Works with R&D to determine pre-clinical and clinical feasibility of new products. • Confers with President and other senior management staff regularly review internal progress and external conditions and discuss required changes in goals or objectives resulting from current status and conditions. • Recruits and trains exempt, non-exempt and consulting clinical affairs personnel • Develops a budget for department to meet organizational goals. Ensures that overall budget schedules are set realistically and attained Skill Requirements: • Analytical – Ability to analyze complex or diverse information; collects and researches data; uses results, intuition and experience to synthesize product specific direction. • Design - Generates creative solutions for clinical programs; demonstrates attention to detail in data collection and analysis. • Problem Solving - Gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations. • Oral Communication – Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds clearly to questions. • Written Communication – Writes clearly and informatively; presents numerical data effectively; able to read and interpret medical, scientific and engineering literature. • Organizational Support - Supports organization's goals and values. • Adaptability & Dependability – Adapts to changes in the work environment; manages competing demands; changes approach or method to best fit the situation; able to deal with frequent change, delays, or unexpected events. Takes responsibility for own actions; keeps commitments; commits to long hours of work when necessary to reach goals. • Innovation - Displays original thinking and creativity; meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas for proof of concept prototypes. • Motivation - Sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence. Education/Training/Experience Requirements: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Education/Experience: • Must have extensive experience developing and executing clinical programs for Class III cardiovascular medical devices, particularly interventional cardiology or ICU-based clinical trials • BS degree in life sciences or engineering plus 15 years of related experience, or equivalent combination of education and experience • Prior experience with personnel management and project management in the context of Class III medical device trials and regulatory submissions is required Language Ability: Ability to read, analyze and interpret the most complex documents. Ability to respond effectively to the most sensitive inquiries or complaints. Ability to write speeches and articles using original or innovative techniques or style. Ability to make effective and persuasive speeches and presentations on controversial or complex topics to management or customers. Math Ability: Ability to apply advanced mathematical and statistical concepts as typically performed by researchers with a graduate degree including sophisticated statistical analysis. Reasoning Ability: Ability to define problems collects data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Computer Skills: Working knowledge of desktop computer and software programs Certificates and Licenses: No certifications required Supervisory Responsibilities: Manages employees in the clinical trials department. Is responsible for the overall direction, coordination, and evaluation of this group. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate. Ability to actively participate in animal experiments. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently required to travel domestically and internationally frequently. The employee is regularly required to sit, talk and hear. The employee is regularly required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. Specific vision abilities required by this job include close vision, distance vision and ability to adjust focus. Ability to work in the engineering lab, academic and contract pre-clinical laboratory during the conduct of animal experiments, and in patient care environments for extended periods is essential. Preferred Experience: • Leading trials under 21CFR50 “Exception to informed consent for emergency research.” • Leading clinical trials evaluating medical device interventions for cardiac arrest. • Leading clinical trials evaluating medical device interventions for acute myocardial infarction. |