Regulatory Affairs Specialist

Integer Holdings Corporation • Plymouth, MN

3d • $73,425 - $107,690

About The Position

The Regulatory Affairs Specialist supports Regulatory Affairs managers and department management by capturing, archiving, and publishing regulatory documents; developing strategies and preparing national and international product-registration submissions; and preparing and maintaining regulatory files, reports, and databases. The role supports regulatory submissions and approvals for Integer-owned devices, reviews change requests requiring regulatory approval, and maintains regulatory decisions, external databases, and product files in accordance with quality-system requirements.

The specialist coordinates responses to customer requests for product and process information, supports customer change notifications, obtains external regulatory documents, and facilitates their legalization or authentication when required. The role may also support internal quality-system audits and participate in regulatory and Notified Body audits, including organizing and tracking responses to findings.

The position contributes to quality-system projects, corrective and preventive actions, quality KPIs, process improvement, and Integer’s manufacturing excellence and market-focused innovation strategies. It supports site planning, validation master plans, metrics, sustained change, workplace organization and visual controls, standardized work, training, associate engagement, and process optimization. The specialist is expected to follow Integer’s values and applicable safety, environmental, security, quality, FDA, and other regulatory requirements; work independently and collaboratively; and contribute to continuous improvement. Other duties may be assigned by the line of supervision.

Requirements

• At least a bachelor’s degree and 1 year of relevant experience are preferred; candidates without the education requirement may be considered with at least 3 years of relevant medical-device or other regulated-industry experience.
• Understanding of the European Medical Device Regulation, U.S. FDA regulations, and other applicable regulations identified in the Quality Manual.
• Ability to work independently and collaboratively with associates and cross-functional teams.
• Solid technical aptitude and ability to contribute to a team or produce technical results individually.
• Effective written and oral communication skills.
• Strong organization and ability to work on and track multiple projects simultaneously.
• Intermediate to advanced Microsoft Office skills, including PowerPoint, Visio, and Project.
• Positive, can-do attitude and belief that failure is not an option.

Nice To Haves

• Bachelor’s degree and at least 1 year of relevant experience.
• At least 3 years of relevant medical-device or other regulated-industry experience as an alternative for candidates who do not meet the education requirement.

Responsibilities

• Capture, archive, and publish regulatory documents and support Regulatory Affairs managers and department management.
• Develop strategies and prepare national and international product-registration submissions for Integer-owned devices, consulting relevant sources for information.
• Review change requests requiring regulatory review and approval for compliance with national and international regulations.
• Prepare and maintain no-file decisions, external regulatory databases, and product files in accordance with quality-system requirements and department procedures.
• Coordinate reviews and responses to customer requests for process and product information and maintain tracking logs.
• Participate in customer change notifications and maintain the associated tracking log.
• Obtain external regulatory documents for customer requests and facilitate legalization, authentication, or apostilling when required.
• Perform or support internal quality-system audits and participate in regulatory and Notified Body audits; organize and track responses to findings as needed.
• Contribute to quality-system projects, process-improvement investigations, corrective and preventive actions, quality KPIs, and adherence to the Quality Management System.
• Support manufacturing excellence and market-focused innovation strategies, including site planning, quality planning, validation master plans, and related improvement initiatives.
• Provide data for weekly and monthly QA/RA metrics and support sustained change and continuous improvement activities.
• Support workplace organization and visual controls (5S), Manufacturing Standard Work, training and certification programs, standardized problem solving, safety programs, improvement-idea systems, and built-in-quality process optimization.
• Follow applicable safety, environmental, security, quality, FDA, company policy, and other regulatory requirements.
• Perform other duties as needed and directed by the line of supervision.

Benefits

• Base salary and a cash-based incentive program.
• Medical, dental, vision, disability, and life insurance.
• Adoption benefits.
• Parental leave after one year.
• Optional employee-paid supplemental life insurance, critical illness, hospital indemnity, and accident insurance.
• 401(k) plan with company matching contributions, with immediate eligibility.
• 80 hours (10 days) of company-designated holidays per year.
• Annual allotment of paid time off.

What This Job Offers

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