Regulatory Affairs Specialist III

By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.At Integer, our values are embedded in everything we do.CustomerWe focus on our customers' successInnovationWe create better solutionsCollaborationWe create success togetherInclusionWe always interact with others respectfullyCandorWe are open and honest with one anotherIntegrityWe do the right things and do things rightJob Summary:The primary purpose of this position is to strategically plan, execute and provide oversight to regulatory activitiesnecessary to obtain and maintain regulatory approvals within the United States and International markets andensure compliance with relevant US, EU, ISO standards and other regulatory requirements based on geographyand product.Accountabilities & Responsibilities:* Adheres to Integer's Values and all safety, environmental, security and quality requirements including, but notlimited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems,U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and otherregulatory requirements.* Works independently, receives minimal guidance* Acts as a resource for colleagues with less experience; may direct the work of other staff members* Responsible for planning, managing and implementing regulatory strategies and product submissions for theUS FDA, EU notified body and other country specific regulatory bodies. Provides strategic input. Participateson Product Development teams, providing a high level of experience in regulatory, strategy, timelines, anddirection.* Prepares US and International submissions for Medical Devices and works with government agencies and/ordistributors to obtain product approval/clearance.* Serves as informational resource for all departments, assists in keeping company informed of US andInternational regulatory requirements. Ensures relevant International, ISO and FDA requirements are met, asrequired and ensures accuracy of submission information.* Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance* Initiates Free Sales Certificate requests and product release authorizations.* Support post-market regulatory compliance activities, which includes review and assessment of changerequests to determine effect of product changes on US and International regulatory strategy and submissionsper standard procedures.* Evaluates post-market incident reports and determine MDR requirements.* Develops and maintains regulatory status documents and submission procedures.* Assists with recall/retrieval documentation and other activities.* Identifies, investigates, evaluates and implements, as appropriate, new methodologies associated withproduct quality and quality systems.* Performs other functions as required.Education & Experience:* Minimum Education: Bachelor's Degree in a related fieldJob Family Group: Regulatory Affairs Career Band Level: P3Job Family: Regulatory FLSA Status: ExemptDate Revised: 14 Jun 2019Regulatory Affairs Specialist IIIInteger Holdings Corporation (ITGR) is one of the largest medical device outsource (MDO) manufacturers in the world serving the cardiac, neuromodulation, orthopedics,vascular, advanced surgical and portable medical markets. The company provides innovative, high-quality medical technologies that enhance the lives of patients worldwide.In addition, it develops batteries for high-end niche applications in energy, military, and environmental markets. The company's brands include Greatbatch Medical, LakeRegion Medical and Electrochem. Additional information is available at www.integer.net.2* Minimum Experience: 3 years of US and International medical device, IVD or pharmaceutical regulatorysubmission/approval experience to include US FDA, EU MDD/AIMD and/or EU MDR, Japan PMDA, AustraliaTGA and China CDA; or 2 years of experience with Master's in Regulatory Affairs.Knowledge & Skills:* Special Skills: Ability to research, compile, summarize and present information. Ability to work throughissues with customers.* Specialized Knowledge: Knowledge of US FDA Quality System Regulations and ISO Requirements.Knowledge of applicable laws which regulate medical device manufacturers.* Other: Skill in working with computers and experience with Microsoft Office SuiteU.S. Applicants: EOE/AA Disability/Veteran