Regulatory Affairs Specialist

Integer • Plymouth, MN

7d

About The Position

The Regulatory Affairs Specialist provides team support to Regulatory Affairs managers and department management by capturing, archiving, and publishing regulatory documents; developing strategies and preparing submissions for national and international product registrations; and preparing and maintaining regulatory files, reports, and databases. The role supports regulatory submissions and approvals for Integer-owned devices, customer requests and notifications, and internal and external audits. It also contributes to quality-system responsibilities, process improvements, manufacturing excellence initiatives, and ongoing quality performance.

The specialist is expected to follow Integer’s values and all applicable safety, environmental, security, quality, FDA, company, and other regulatory requirements. The role calls for both independent work and collaboration with associates and cross-functional teams, while supporting continuous improvement and adherence to Integer’s Quality Management System.

Requirements

• A bachelor’s degree and at least 1 year of relevant experience; candidates without the education requirement may be considered with at least 3 years of relevant medical-device or other regulated-industry experience.
• Understanding of European Medical Device Regulation, U.S. FDA regulations, and other applicable regulations identified in the Quality Manual.
• Technical aptitude and ability to contribute to a team or produce technical results independently.
• Written and oral communication competencies.
• Strong organization skills and ability to work on and track multiple projects simultaneously.
• Intermediate to advanced Microsoft Office skills, including PowerPoint, Visio, and Project.
• Ability to work independently and collaboratively with associates and cross-functional teams.
• Commitment to Integer’s values and compliance with applicable safety, environmental, security, quality, company, and regulatory requirements.

Nice To Haves

• A bachelor’s degree and at least 1 year of relevant experience, if not being used to meet the stated minimum qualification.

Responsibilities

• Capture, archive, and publish regulatory documents.
• Develop strategies and prepare national and international product registration submissions for Integer-owned devices.
• Consult multiple sources for information to prepare product submissions and support regulatory submissions.
• Review Change Requests requiring regulatory review and approval to ensure compliance with national and international regulations.
• Prepare and maintain no-file decisions, external regulatory databases, and product files in line with Integer quality-system requirements and department procedures.
• Coordinate reviews and responses to customer requests and queries related to processes and products, and maintain tracking logs.
• Participate in customer notifications of changes and maintain the associated tracking log.
• Obtain external regulatory documents to support customer requests and facilitate their legalization, authentication, or apostilling as required.
• Perform or support internal quality-system audits and participate in regulatory and Notified Body audits.
• Compile, organize, and track responses to audit findings as needed.
• Work on projects using Integer’s quality-management-system methodologies to investigate process-improvement opportunities.
• Adhere to Integer’s Quality Management System, contribute to corrective and preventive actions, and support quality KPIs and quality improvement.
• Support Manufacturing Excellence and Market Focused Innovation strategies.
• Participate in or lead site Hoshin Planning, Quality Planning, validation master plans, and associated quality-improvement initiatives.
• Provide data for QA/RA weekly and monthly metrics.
• Support sustained change, including initiation and completion of customer change notifications and continuous-improvement activities.
• Support workplace organization and visual controls (5S), Manufacturing Standard Work, and training and certification programs where applicable.
• Support associate engagement through standardized problem-solving methods, behavior-based safety programs, and improvement idea systems.
• Support systems and process optimization through adoption of built-in-quality principles.
• Actively support Integer Environmental, Health & Safety programs and pursue defined goals and objectives.
• Generate continuous-improvement suggestions and support their implementation.
• Perform other duties as needed and directed by the line of supervision.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Disability insurance
• Life insurance
• Adoption benefits
• Parental leave after one year
• Optional supplemental life, critical illness, hospital indemnity, and accident insurance programs
• 401(k) plan with company matching contributions
• 80 hours (10 days) of company-designated holidays per year
• Annual allotment of paid time off
• Cash-based incentive program

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level