Regulatory Affairs Specialist

The Regulatory Affairs Specialist is responsible for investigating and supporting regulatory policy necessary to obtain regulatory approval for the organizations products Work with RA Leadership and other members of the RA team to set strategy for regulatory approval to introduce new products to market evaluate regulatory requirements and prepare regulatory submissions Essential Functions and Main Duties Prepare regulatory submissions for new products and product changes as required to ensure timely approval for clinical studies and product market release Review significant regulatory strategies with leadership team as necessary and negotiate submission steps with regulatory bodiesProvide on going support to core and project teams for regulatory issues and questions Investigate interpret and apply regulations and guidance appropriately for situationsProvide product information to RA Leadership to enable development of strategies and requirements to communicate information to leadership teamProvide regulatory support for currently marketed products as necessary This includes reviewing labeling promotional materials changes to existing devices and documentation Prepare submissions and reports for regulatory agencies as requiredWork with RA Leadership and other members of the RA team to help support discussions with FDA or other regulatory agencies as needed All significant changes will be reviewed with the RA LeadershipParticipate in the development of general strategies including how to interact more effectively with regulatory agencies and agency personnelMaintain Regulatory Affairs product files to support compliance with regulatory requirementsKeeps current on global directives harmonized standards and procedures and communicates changes that may affect cross functional areasReview training promotional and advertising pieces for assigned product linesSupport maintenance of facility licenses such as FDA Establishment Registrations California FDB Licensing Health Canada etcSupport Quality Systems Projects as requiredAdhere to all company policies procedures and business ethics codesDuties may be modified or assigned at any time based on business needQualifications Education Certification Experience Required Bachelors degree in science engineering or related discipline2 years of experience in regulatory affairsDemonstrated proficiency with global regulatory planning and strategy for submission preparation including but not limited to 510k IDE supplements and amendmentsClinical Quality or Regulatory compliance experienceExperience with product lifecycle management premarket and post market product line supportStrong understanding and wide application of technical or regulatory principles theories and concepts; general knowledge of other related disciplinesLevel and compensation depend on location experience education and skillsCompetencies Required Ability to provide solutions to a wide range of difficult problems Solutions are imaginative thorough practical and consistent with organizational objectivesAbility to analyze a wide range of information including conflicting and ambiguous inputs and propose solutionsStrong organizational time management and project management skillsStrong knowledge of Microsoft OfficeEffective presentation and interpersonal skillsSelf motivationExcellent verbalwritten communication skillsStrong attention to detail and accuracyAbility to communicate persuasively in a manner that supports approvals and other key company goalsobjectivesMust be able to communicate verbally and in writing and to receive and understand verbal and written instructions in EnglishAble to work effectively both independently and in a collaborative team environmentCompensation The anticipated range for this position is 80000 to 100000 Actual placement within the range is dependent on multiple factors including but not limited to skills education experience and location Perks and Benefits Visit our Career page to learn more about Perks & Benefits and working at Nihon Kohden America Working Conditions Schedule The regular hours for this full time position are 800 am to 500 pm Monday Friday unless otherwise stated by the department manager Holiday weekend and evening work hours may be required Regular hours may vary due to the needs of the organization or department and are subject to change at any time at the Companys discretion Physical Generally may require some reaching bending stooping squatting crawling kneeling pushing pulling lifting carrying up to 20 pounds finger dexterity repetitive motions standing walking sitting hearing visual acuity and color vision More specific details may be provided as needed or requested Travel Approximately 10 Access to Customer Sites Not Required Nihon Kohden America is committed to maintaining a professional and respectful workplace free from discrimination harassment and retaliation and welcomes all qualified candidates to apply Employment decisions are based on qualifications experience and business needs without regard to legally protected characteristics This policy applies to all employment actions including recruitment hiring promotion compensation training and other workplace practices Nihon Kohden America complies with all applicable federal state and local laws regarding equal employment opportunity Employees and applicants will not be subject to harassment or retaliation for asserting their legal rights Questions or concerns regarding this policy may be directed to Human Resources at HREmployeeServicesnihonkohdencom