Regulatory Affairs Specialist III

4 weeks ago

Minneapolis, United States Integer Holdings Corporation Full time

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

Job Summary:
The primary purpose of this position 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 US, EU, ISO standards and other regulatory requirements based on geography
and product.
Accountabilities & Responsibilities:
* Adheres to Integer's Values and all safety, environmental, security and quality requirements including, but not
limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems,
U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other
regulatory requirements.
* Works independently, receives minimal guidance
* Acts as a resource for colleagues with less experience; may direct the work of other staff members
* Responsible for planning, managing and implementing regulatory strategies and product submissions for the
US FDA, EU notified body and other country specific regulatory bodies. Provides strategic input. Participates
on Product Development teams, providing a high level of experience in regulatory, strategy, timelines, and
direction.
* Prepares US and International submissions for Medical Devices and works with government agencies and/or
distributors to obtain product approval/clearance.
* Serves as informational resource for all departments, assists in keeping company informed of US and
International regulatory requirements. Ensures relevant International, ISO and FDA requirements are met, as
required and ensures accuracy of submission information.
* Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance
* Initiates Free Sales Certificate requests and product release authorizations.
* Support post-market regulatory compliance activities, which includes review and assessment of change
requests to determine effect of product changes on US and International regulatory strategy and submissions
per standard procedures.
* Evaluates post-market incident reports and determine MDR requirements.
* Develops and maintains regulatory status documents and submission procedures.
* Assists with recall/retrieval documentation and other activities.
* Identifies, investigates, evaluates and implements, as appropriate, new methodologies associated with
product quality and quality systems.
* Performs other functions as required.
Education & Experience:
* Minimum Education: Bachelor's Degree in a related field
Job Family Group: Regulatory Affairs Career Band Level: P3
Job Family: Regulatory FLSA Status: Exempt
Date Revised: 14 Jun 2019
Regulatory Affairs Specialist III
Integer Holdings Corporation (ITGR) is one of the largest medical device outsource (MDO) manufacturers in the world serving the cardiac, neuromodulation, orthopedics,
vascular, advanced surgical and portable medical 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 www.integer.net.
2
* Minimum Experience: 3 years of US and International medical device, IVD or pharmaceutical regulatory
submission/approval experience to include US FDA, EU MDD/AIMD and/or EU MDR, Japan PMDA, Australia
TGA and China CDA; or 2 years of experience with Master's in Regulatory Affairs.
Knowledge & Skills:
* Special Skills: Ability to research, compile, summarize and present information. Ability to work through
issues with customers.
* Specialized Knowledge: Knowledge of US FDA Quality System Regulations and ISO Requirements.
Knowledge of applicable laws which regulate medical device manufacturers.
* Other: Skill in working with computers and experience with Microsoft Office Suite

U.S. Applicants: EOE/AA Disability/Veteran

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