Senior Regulatory Affairs Specialist - Integer : Job Details

Senior Regulatory Affairs Specialist

Integer

Job Location : Minneapolis,MN, USA

Posted on : 2025-08-17T00:38:41Z

Job Description :

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 oversee regulatory activities necessary to obtain and maintain regulatory approvals within the United States and international markets, ensuring compliance with FDA, EU, ISO, and other standards.

Key Accountabilities and Responsibilities

  • Adhere to Integer's core beliefs and all safety and quality requirements.
  • Develop US and international regulatory strategies for product submissions, including testing needs.
  • Provide strategic input to product development teams regarding regulatory, strategy, timelines, and direction.
  • Prepare US and international submissions and coordinate with agencies/distributors for product approval/clearance.
  • Serve as a resource for all departments on regulatory requirements, ensuring compliance with international, ISO, and FDA export standards.
  • Initiate FDA export approvals and product release authorizations.
  • Review ECOs and assess the impact of product changes on regulatory strategies and submissions.
  • Evaluate post-market incident reports and determine MDR requirements.
  • Assist with recalls, retrievals, and documentation activities.
  • Maintain regulatory status documents and submission procedures.
  • Identify and implement new methodologies related to product quality and systems.
  • Perform other duties as required.

    • Job Requirements

    • Bachelor's degree in a related field.
    • 7+ years of US and international medical device regulatory experience, including FDA, MDD, PMDA, TGA, and TPD.
    • Knowledge of FDA QSR and ISO standards, applicable laws, and ability to resolve complex issues.
    • Strong communication and technical writing skills; experience with managing, auditing, training, and FDA inspections.
    • Proficiency with computers, spreadsheets, and word processing software.

    Salary Range: $113,025 - $165,770

    Our total rewards program includes base salary, incentive programs, comprehensive benefits, and various paid leaves. U.S. applicants are encouraged to apply, with veterans and individuals with disabilities particularly welcomed.

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