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Integer

Senior Regulatory Affairs Specialist

Salary$113k – $166k
LocationPlymouth, MN
Work modeon-site
Typefull-time
Company size10,000+ people
First seen1w ago
Last seen3d ago
About the company
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
About the role
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
13.
Other: Skill in working with computers and experience with spreadsheet and word-processing
software.
Benefits
Salary range $113,025 - $165,770
#IND1
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.
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