Senior Regulatory Affairs Specialist

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 rightThe primary purpose of this job 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 FDA, EU, ISO, and other regulatory requirements and standards.Key Accountabilities and Responsibilities1. Adheres to Integer's Core Beliefs and all safety and quality requirements.2. Develops US and International regulatory strategies for product submissions, identifying needs for bench,animal and clinical testing.3. Provides strategic input. Participates on Product Development teams, providing a high level of experience inregulatory, strategy, timelines, and direction.4. Prepares US and International submissions and work with government agencies and/or distributors to obtainproduct approval/clearance.5. Serves as informational resource for all departments, assisting in keeping company informed of US andInternational regulatory requirements. Ensures relevant International, ISO and FDA Export requirements aremet, as required and ensures accuracy of submission information.6. Initiates FDA export approval requires and product release authorizations.7. Reviews ECO’s and assess effect of product changes on US and International regulatory strategy andsubmissions per standard procedures.8. Evaluates post-market incident reports and determine MDR requirements.9. Assists with recall/retrieval documentation and other activities.10. Develops and maintains regulatory status documents and submission procedures.11. Identifies, investigates, evaluates and implements as appropriate new methodologies associated with productquality and quality systems.12. Performs other functions as required.Job RequirementsMinimum Education: Bachelor’s degree in a related field.Minimum Experience: 7+ years of US and International medical device regulatory submission/approvalexperience, to include FDA, MDD, PMDA, TGA, and TPD experience.Specialized Knowledge:Knowledge of FDA Quality System regulations and ISO requirements. Knowledge of allapplicable laws which regulate medical device manufacturers. Ability to work throughdifficult issues with suppliers and customers.Special Skills:Strong communication and technical writing skills. Skill in management, precisionmeasurement, auditing, training, supplier/customer relations, FDA inspections, ISO9000.Other: Skill in working with computers and experience with spreadsheet and word-processingsoftware.Salary range $113,025 - $165,770Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success. Our compensation program includes base salary and a cash-based incentive program supporting our pay-for-performance philosophy. We provide a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits. Parental leave is available after one year. Optional employee-paid programs include supplemental life insurance, critical illness, hospital indemnity and accident insurance. Employees are immediately eligible to participate in the 401(k) plan with company matching contributions. We provide 80 hours (10 days) of company designated holidays per year plus an annual allotment of paid time off.U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply. #J-18808-Ljbffr