Senior Regulatory Affairs Specialist

integer; Plymouth (MN); On-site; USD 110,000 - 150,000; Full time

Job summary

Integer is seeking a regulatory affairs professional to strategically plan, execute, and oversee activities ensuring US and international approvals while complying with FDA, ISO, and related standards. You will collaborate with Product Development teams to drive submissions and maintain compliance across markets.

The role emphasizes coordinating with agencies and distributors, evaluating post-market reports, and guiding regulatory strategy to support global product launches.

Qualifications

• Strategically plan, execute and provide oversight to regulatory activities to obtain and maintain regulatory approvals.
• Develop US and International regulatory strategies for product submissions.
• Prepare US and International submissions and coordinate with agencies and distributors.

Responsibilities

• Adheres to Integer's Core Beliefs and all safety and quality requirements.
• Develops US and International regulatory strategies for product submissions, identifying needs for bench, animal and clinical testing.
• 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 and work 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.
• 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.
• Evaluates post-market incident reports and determine MDR requirements.
• Assists with recall/retrieval documentation and other activities.

Skills

Regulatory strategy

US FDA submissions

International regulatory

Cross-functional collaboration

Regulatory compliance

Project oversight

Job description

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

• Adheres to Integer's Core Beliefs and all safety and quality requirements.
• Develops US and International regulatory strategies for product submissions, identifying needs for bench, animal and clinical testing.
• 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 and work 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.
• Evaluates post-market incident reports and determine MDR requirements.
• Assists with recall/retrieval documentation and other activities.