Senior Regulatory Affairs Specialist job opportunity at Integer Holdings Corporation.

Home Jobs In United States Of America Tag: Job Senior Regulatory Affairs Specialist position at Integer Holdings Corporation


DateMore Than 30 Days Ago bot
Integer Holdings Corporation Senior Regulatory Affairs Specialist
Experience: 7-years
Pattern: full-time
Country:
apply Apply Now
Salary:
Status:

Job

Copy Link Report
degreeAssociate
loacation Plymouth, MN, United States Of America
loacation Plymouth, MN....United States Of America

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. Salary range $113,025 - $165,770 

 Our 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.

Other Ai Matches

Facilities and Maintenance Technician Applicants are expected to have a solid experience in handling Job related tasks
Supervisor, Engineering Applicants are expected to have a solid experience in handling Engineering related tasks
Associate Machine Operator-1 Applicants are expected to have a solid experience in handling Job related tasks
Associate Machine Operator-1 Applicants are expected to have a solid experience in handling Job related tasks
Quality Inspector I-1 Applicants are expected to have a solid experience in handling Job related tasks
Manufacturing Team Member II Applicants are expected to have a solid experience in handling Job related tasks
Machine Operator Applicants are expected to have a solid experience in handling Job related tasks
Manufacturing Team Member II - 2nd shift Applicants are expected to have a solid experience in handling Job related tasks
Tijuana - Machine Operator-3 Applicants are expected to have a solid experience in handling Job related tasks
R&D Engineer II ( Parkmore East Galway) Applicants are expected to have a solid experience in handling Job related tasks
remote-jobserver Remote
Solutions Architect IV - Datasphere Applicants are expected to have a solid experience in handling Job related tasks
Manufacturing Team Member II - 3rd shift Applicants are expected to have a solid experience in handling Job related tasks
remote-jobserver Remote
Manager, ITQA Testing Applicants are expected to have a solid experience in handling ITQA Testing related tasks
Senior Mechanical Design Engineer Applicants are expected to have a solid experience in handling Job related tasks
Manufacturing Team Member II - 1st shift Applicants are expected to have a solid experience in handling Job related tasks
remote-jobserver Remote
Sr. Director, PMO Applicants are expected to have a solid experience in handling PMO related tasks
Associate Machine Operator -Laser 12 hrs night Applicants are expected to have a solid experience in handling Job related tasks
Team Lead Subassembly - 12 Hour Days Applicants are expected to have a solid experience in handling Job related tasks
Process Development Engineer III Applicants are expected to have a solid experience in handling Job related tasks
Senior Quality Engineer Applicants are expected to have a solid experience in handling Job related tasks
Manager, Domestic Tax Applicants are expected to have a solid experience in handling Domestic Tax related tasks
Machine Operator Applicants are expected to have a solid experience in handling Job related tasks
Senior Engineer - Manufacturing Applicants are expected to have a solid experience in handling Job related tasks