The primary purpose of this job is to develop strategies for worldwide governmental approval to introduce new and modified medical devices to market, provide advice on regulatory requirements, prepare global regulatory submissions and negotiate their approval. Assists with the training of senior regulatory affairs personnel and provides work direction on projects of large scale.
International and Domestic responsibilities with medical devices include PMA, 510k, design dossier, international registrations, notified body submissions, ANVISA, TGA, Japan, US regulation knowledge required
1. Adheres to Integer 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. Develops unique strategies for new products using technical expertise and global experiences.
5. Responsible for the collection and presentation of prospective clinical data to support the safety and effectiveness of new products.
6. Prepares US and International regulatory submissions and work with government agencies and/or distributors to obtain approval/clearance for new and modified products.
7. 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.
8. Reviews and assesses effect of product changes on US and International regulatory strategy and submissions per standard procedures.
9. Evaluates post-market incident reports and determine MDR requirements.
10. Assists with recall/retrieval documentation and other activities.
11. Develops and maintains regulatory status documents and submission procedures.
12. Identifies, investigates, evaluates and implements as appropriate new methodologies associated with product quality and quality systems.
13. Maintains Regulatory Affairs product files to support compliance with regulatory requirements.
14. Provides support to currently-marketed products as necessary, including reviewing labeling, promotional material, product changes, and documentation for changes requiring regulatory action.
Bachelor’s degree in Engineering, Physical/Biological/Health Sciences.
10 years of US and International medical device regulatory affairs including 3-5 years regulatory experience with Class III Devices.
Demonstrated proficiency with regulatory planning/strategy; negotiation skills; project management skills; knowledgeable in medical device design, manufacturing, product development; and proficiency in worldwide regulatory requirements and procedures. Experience with active implantable medical devices.
Strong oral and written communication skills, including technical writing skill. Skill working with computer systems including proficiency in spreadsheet and word-processing software.
Internal Number: R834
About Integer Holdings Corp
When Greatbatch,™ Inc. and Lake Region Medical™ merged in October of 2015, we became one of the world’s largest medical device outsource manufacturers. Marking this major milestone, we reintroduced ourselves as Integer Holdings Corporation and became Integer™.
There is great purpose in words and how we use them to identify who we are. “Integer” simply means complete, whole or comprehensive, and ideally represents the union of our brands—Greatbatch, Lake Region Medical and Electrochem™. It also exemplifies our more comprehensive product and service offerings, as well as a new dimension in our combined capabilities.