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. Customer We focus on our customers’ success Innovation We create better solutions Collaboration We create success together Inclusion We always interact with others respectfully Candor We are open and honest with one another Integrity We do the right things and do things right The primary purpose of this job is to strategically plan, execute and provide oversight to regulatory activities necessary to obtain and maintain regulatory approvals within the United States and International markets and ensure compliance with relevant FDA, EU, ISO, and other regulatory requirements and standards. Key Accountabilities and Responsibilities 1. 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 in regulatory, strategy, timelines, and direction. 4. Prepares US and International submissions and work with government agencies and/or distributors to obtain product approval/clearance. 5. Serves as informational resource for all departments, assisting in keeping company informed of US and International regulatory requirements. Ensures relevant International, ISO and FDA Export requirements are met, 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 and submissions 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 product quality and quality systems. 12. Performs other functions as required. Job Requirements Minimum Education: Bachelor’s degree in a related field. Minimum Experience: 7 years of US and International medical device regulatory submission/approval experience, to include FDA, MDD, PMDA, TGA, and TPD experience. Specialized Knowledge: Knowledge of FDA Quality System regulations and ISO requirements. Knowledge of all applicable laws which regulate medical device manufacturers. Ability to work through difficult issues with suppliers and customers. Special Skills: Strong communication and technical writing skills. Skill in management, precision measurement, auditing, training, supplier/customer relations, FDA inspections, ISO 9000. Other: Skill in working with computers and experience with spreadsheet and word-processing software. U.S. Applicants: EOE/AA Disability/Veteran Integer Holdings Corporation (NYSE:ITGR) is the largest medical device outsource (MDO) manufacturer in the world serving the cardiac, neuromodulation, orthopedics, vascular, advanced surgical and power solution 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, Lake Region Medical and Electrochem. Additional information is available at https://integer.net. Integer is committed to equal opportunity for all, without regard to race, color, religion, creed, national origin, ancestry, ethnicity, sex (including pregnancy and gender), age, physical or mental disability, citizenship, veteran or military status past, current, or prospective service in the uniformed services, genetic information, sexual orientation, gender identity, marital status, or any other characteristic protected under applicable legally recognized protected basis under federal, state or local law. Greatbatch Integer complies with the Americans with Disabilities Act (ADA), as amended by the ADA Amendments Act, and all applicable state or local law. Consistent with those legal requirements, Integer will make reasonable accommodations for qualified individuals with a known physical or mental limitations of otherwise qualified employees and applicants with a disability if such accommodation would allow the individual to perform the essential functions of the job, unless the accommodation would impose an undue hardship on the operation of our business. If you are interested in applying for an employment opportunity and feel believe you need a reasonable accommodation pursuant to the ADA, please contact us at 716-759-5631. All postings presume work will be performed entirely outside of Hawaii, California, Colorado, Maine, Connecticut, and Washington, and New York (where management is based outside of NY state) To review the Integer U.S. Applicant Privacy Statement click here.