VP, Clinical and Regulatory Affairs - Emerging Leader in the Neuromodulation Space

VP, Clinical & RegulatoryWorld Leader in Bionic Innovations Our Client, a world leader in the development of cutting-edge Human Bionics Devices, is currently seeking a Vice President of Clinical and Regulatory Affairs to be based in Minneapolis, MN. Their award-winning bionic advancements are groundbreaking in the medical device industry and they are strategically positioned at the helm of the fast growing Neurotechnology Sector. In fact, the market research firm Medtech rates the Neurotechnology sector as the #1 growth sector for 2008 and expects growth to rise from $3.6B in worldwide sales in 2008 to $8.8B in 2012.   The company’s Neurobionics unit is dedicated to the development of bionic devices, such as sensors, artificial intelligence modules and dedicated stimulators. Human Bionics is a discipline dedicated to the creation of devices that can instantaneously interact with the human body to replace or restore biomechanical or physiological functions. To achieve this, the products must contain components capable of measuring the behaviour of targeted bodily functions, interpreting this measurement via artificial intelligence and providing instructions.This publicly-traded medical device leader headquartered in Canada, with a regional office in Minnesota, is brimming with opportunities for growth for the right caliber of individual. Along with a solid work environment and opportunity for growth, our client provides an attractive array of benefits and a competitive compensation package.  Summary The Vice President of Clinical & Regulatory Affairs will report to the Chief Operating Officer of a Major Business Unit and also become a member of the Clinical and Regulatory Affairs group. The VP of Clinicals and Regulatory Affairs will be responsible for all clinical study, and regulatory affairs of neuromodulation division of the company.  Resposibilities·  Oversee the clinicals department·  Ensure proper study design to achieve the desired outcome ·  Manage feasibility, therapy, and product related clinical studies with the support of the clinical department·  Interface with EU Notified Body for appropriate design of studies in support of product approvals·  Prepare all technical files to Notified Body for CE marking of products·  Prepare regulatory submissions to government health organizations·  Develop strategies for worldwide regulatory approval and introduction of new products to market.·  Lead all interactions with FDA, including IDE, PMA, Pre-PMA, Inspections, etc. for conducting studies, site evaluations, and post market interactions.·  Lead all internal activities related to US and OUS submissions·  Lead all communications with regulatory agencies·  Prepares US and international submissions and provides support for major market regulatory approvals.·  Review of product labeling, and changes for regulatory compliance ·  Provide post-market support and ensure regulatory compliance of market-released products.·  Conduct and document Post Market Surveillance activities.·  Ensure proper system for Medical Device Reporting (MDR’s) and Vigilance Reporting.·  Work closely with Marketing, Manufacturing, Quality Assurance, Engineering and New Product Development teams to provide strategic regulatory guidance and review ·  Lead researching and interpreting International/emerging regions regulations·  Ensure creation of internal procedures that capture clinical and regulatory processes. Requirements Bachelor’s degree.Minimum 10 years of related work experience in regulatory affairs roles at companies with Class III medical productsRegulatory experience with implantable active electronics medical devicesExperience with CE mark submissionsExperience with Canadian submissionsExperience with PMA submissionsExperience with the entire US regulatory cycle from beginning to end at least onceConcise, organized, able to multi-task with the ability to prioritizeDemonstrated proficiency with regulatory planning/strategy, and submission planning/preparation A good working knowledge of Clinical Studies and Pre-clinical researchExcellent presentation skills and ability to communicate effectively with senior management and outside entities, including investorsThe ability to juggle and prioritize multiple projects in various stages concurrentlyStrong interpersonal, communication, and analytical skillsAbility to effectively plan, organize, monitor, execute, and measure success of a project.Proven experience of achieving results through influence and leadershipProven experience in managing groups and building teams   MRINetwork is the largest and most successful search organization in the world. Each MRINetwork office is a single point of contact to over 1,100 offices in more than 37 countries, our candidates have access to the right jobs virtually anywhere in the world. LOCATION: Minneapolis, MN 55422 JOB CATEGORY: Biotech/R&D/Science TYPE: Full Time, Employee SALARY: 150,000.00 - 170,000.00 USD /yearCompensation will also include Bonus and Stock Options COMPANY: MRINetwork CONTACT NAME: Sarah Salukas EMAIL: Apply by Email