Advanced Regulatory Affairs Officer

2 weeks ago

Minneapolis, Minnesota, United States Integer Holdings Corporation Full time

Company Overview:
Integer Holdings Corporation is a leading global provider of medical device outsourcing solutions, dedicated to enhancing patient care through innovative technologies. Our commitment to quality and excellence drives our success in the cardiac, neuromodulation, orthopedics, vascular, advanced surgical, and portable medical markets.

Core Values:
At Integer, we believe in fostering a culture that embraces diversity and collaboration. Our core values guide our actions and decisions:

  • Customer Focus: Prioritizing the success of our clients.
  • Innovation: Striving for superior solutions.
  • Collaboration: Achieving success as a unified team.
  • Inclusion: Engaging respectfully with all individuals.
  • Candor: Maintaining transparency and honesty.
  • Integrity: Upholding ethical standards in all endeavors.

Position Summary:
The Regulatory Affairs Specialist III plays a pivotal role in the strategic planning and execution of regulatory activities essential for securing and maintaining approvals in both domestic and international markets. This position ensures compliance with applicable US, EU, ISO standards, and other regulatory requirements tailored to specific geographies and products.

Key Responsibilities:
- Uphold Integer's values and adhere to all safety, environmental, security, and quality protocols, including Quality Management Systems (QMS) and FDA regulations.
- Operate independently with minimal supervision while serving as a resource for less experienced colleagues.
- Lead the planning, management, and implementation of regulatory strategies and submissions for various regulatory bodies, including the US FDA and EU notified bodies.
- Prepare and submit documentation for medical devices to government agencies and distributors to secure product approvals.
- Act as a key informational resource across departments, ensuring the organization remains informed of regulatory requirements.
- Recommend necessary modifications for labeling, manufacturing, marketing, and clinical protocols to ensure compliance.
- Initiate requests for Free Sales Certificates and product release authorizations.
- Support post-market compliance activities, including the review of change requests and evaluation of incident reports for regulatory implications.
- Develop and maintain regulatory status documentation and submission procedures.
- Assist with recall and retrieval documentation as needed.
- Identify and implement new methodologies to enhance product quality and quality systems.

Qualifications:
- Education: Bachelor’s Degree in a relevant field.
- Experience: A minimum of 3 years in regulatory submissions and approvals for medical devices, IVD, or pharmaceuticals, including familiarity with US FDA and EU regulations, or 2 years with a Master’s in Regulatory Affairs.

Skills Required:
- Strong research and analytical skills with the ability to compile and present information effectively.
- In-depth knowledge of US FDA Quality System Regulations and ISO requirements.
- Proficiency in Microsoft Office Suite and other relevant software.

Equal Opportunity Employment:
Integer Holdings Corporation is an equal opportunity employer, committed to fostering a diverse and inclusive workplace.

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