Regulatory Affairs Specialist-US Remote

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

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.

Job Summary: The primary purpose of this job is to execute and provide input on 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

Adheres to Integer Core Beliefs and all safety and quality requirements.
Develops international regulatory strategies for product submissions, identifying and tracking international requirements.
Works with minimal consultation/guidance from senior department members, participates on Product Development teams, providing input in regulatory, strategy, timelines, and direction.
Assists in the preparation of US and International submissions and works with government agencies and/or distributors to obtain product approval/clearance.
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.
Initiates FDA export approval requires and product release authorizations.
Reviews ECO's and assess effect of product changes on US and International regulatory strategy and submissions per standard procedures.
Assists with recall/retrieval documentation and other activities.
Develops and maintains regulatory status documents and submission procedures and international regulatory requirements database.
Assists senior staff with implementation of 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

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, sum

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

This position can be remote within the US, travel will be involved less than 25%.

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