Integer Holdings Corporation

Regulatory Affairs Specialist – III

Integer Holdings Corporation

full-time

Posted on:

Location Type: Hybrid

Location: Palm Harbor • Florida • Minnesota • United States

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About the role

  • The primary purpose of this job is to provide team support to Regulatory Affairs managers and department management in being responsible for ensuring compliance to all relevant regulations and standards.
  • Develop strategies and prepare submissions for national and international product registrations.
  • Prepares and maintains regulatory files, regulatory reports, and databases.
  • You adhere 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.
  • You will be responsible to prepare national and international regulatory submissions for Integer owned devices.
  • You will provide team support and leadership for product submissions and consult with multiple sources for information in order to prepare submissions.
  • You will review Change Requests that require regulatory review and approval to ensure compliance with national and international government regulations.
  • You will prepare and maintain no-file decisions, external regulatory databases (ex. FDA FURLS, GUDID, EUDAMED, etc.), and product files consistent with Integer quality system requirements and department procedures.
  • You will actively support the sales and marketing team and develop regulatory strategies where required.
  • You will actively support projects from new product introduction (NPI) and R&D and develop regulatory strategies.
  • You will participate in risk management activities.
  • You will attend project meeting attendance and provide regulatory assessments and required technical feedback, as required.
  • You will coordinate the review of and responses to customer requests/queries for information related to process and products and maintain respective tracking logs.
  • You will participate in customer notification of changes and assist in maintaining respective tracking log.
  • You will obtain external regulatory documents in support of customer requests (ex. CFG’s, CFS’s) and facilitate the legalization/authentication/apostilling of such documents, as required.
  • You may perform and support internal quality system audits in accordance with Integer quality management system procedures and according to the external requirements as indicated in the Integer Quality Manual.
  • You will participate in regulatory and Notified Body audits as a regulatory team member in either back room or front room activities and may compile, organize and track responses to findings.
  • You will perform work on projects where you will follow Integer’s standard quality management system methodologies to investigate opportunities for process improvements.
  • You are expected to collaborate with others in the exchange of information, ask questions and regularly check for understanding in support of your development as a regulatory professional.
  • You may carry out trending for field complaints and present to leadership.
  • Assist in CAPA investigation and root cause analysis, and performance of effectiveness activities.
  • You may perform other duties as needed and as directed by your line of supervision.

Requirements

  • Preferably, you have earned, as a minimum, a bachelor’s degree and have at least 3 years of relevant experience.
  • Candidates who do not meet the education requirement may be considered if they have a minimum of 5 years’ relevant medical device or other regulated industry experience.
  • You will demonstrate the ability to work independently as well as collaboratively with other associates and cross functional teams.
  • You have a good understanding of the European Union Medical Device Regulation, the US FDA regulations and other applicable regulations identified in the Quality Manual.
  • You demonstrate a solid technical aptitude with the ability to be an effective contributor to a team or produce results of a technical nature as an individual.
  • You demonstrate competencies in both written and oral communications.
  • You are highly organized and able to work and track multiple projects simultaneously.
  • You possess intermediate to advanced skills using Microsoft Office (PowerPoint, Visio, Project, etc.).
  • Preferably, you possess a lead auditor qualification.
  • You possess a positive, can-do attitude with an underlying belief that failure is not an option.
Benefits
  • Comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits.
  • Parental leave is available after one year.
  • Optional employee-paid programs include supplemental life insurance, critical illness, hospital indemnity and accident insurance.
  • Employees are immediately eligible to participate in the 401(k) plan with company matching contributions.
  • 80 hours (10 days) of company designated holidays per year plus an annual allotment of paid time off.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
regulatory submissionsregulatory compliancerisk managementCAPA investigationroot cause analysisquality management systemstechnical aptitudeproject management
Soft skills
collaborationcommunicationorganizational skillsindependent workteam supportleadershipproblem-solvingattention to detail
Certifications
lead auditor qualification