Regulatory Affairs Specialist III

Integer Holdings Corporation • Plymouth, MN

1d • $84,150 - $127,500 • Remote

About The Position

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.

Requirements

• Bachelor's degree and at least 3 years of relevant experience, OR a minimum of 5 years’ relevant medical device or other regulated industry experience.
• Ability to work independently as well as collaboratively with other associates and cross functional teams.
• Good understanding of the European Union Medical Device Regulation, the US FDA regulations and other applicable regulations identified in the Quality Manual.
• Solid technical aptitude with the ability to be an effective contributor to a team or produce results of a technical nature as an individual.
• Competencies in both written and oral communications.
• Highly organized and able to work and track multiple projects simultaneously.
• Intermediate to advanced skills using Microsoft Office (PowerPoint, Visio, Project, etc.)

Nice To Haves

• Lead auditor qualification.

Responsibilities

• Prepare national and international regulatory submissions for Integer owned devices.
• Provide team support and leadership for product submissions and consult with multiple sources for information in order to to prepare submissions.
• Review Change Requests that require regulatory review and approval to ensure compliance with national and international government regulations.
• 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.
• Actively support the sales and marketing team and develop regulatory strategies where required.
• Actively support projects from new product introduction (NPI) and R&D and develop regulatory strategies.
• Participate in risk management activities.
• Attend project meeting attendance and provide regulatory assessments and required technical feedback, as required.
• Coordinate the review of and responses to customer requests/queries for information related to process and products and maintain respective tracking logs.
• Participate in customer notification of changes and assist in maintaining respective tracking log.
• 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.
• 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.
• 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.
• Perform work on projects where you will follow Integer’s standard quality management system methodologies to investigate opportunities for process improvements.
• Collaborate with others in the exchange of information, ask questions and regularly check for understanding in support of your development as a regulatory professional.
• Carry out trending for field complaints and present to leadership.
• Assist in CAPA investigation and root cause analysis, and performance of effectiveness activities.
• Embed Quality within the Regulatory discipline – “I own Quality.”
• Be a standard bearer for Quality in everything we do at Integer, by assuring adherence to our Quality Management System (QMS), facilitating and/or contributing to corrective and preventive actions, and contributing to the successful attainment of our quality KPI’s and journey to 5 Sigma.
• Perform other duties as needed and as directed by your line of supervision.
• Provide support of Integer’s Manufacturing Excellence and Market Focused Innovation Strategies.
• Participation or Leadership in Site Hoshin Planning, Quality Planning, Validation master plans and associated quality improvement imperatives.
• Provide leadership as required for QA RA weekly and monthly metrics, supporting the walk to 5 sigma.
• Leadership of Sustained Change ensuring customer change notifications are initiated and completed, as necessary, and supporting continuous improvement activities as required.
• Support the standardisation of workplace organization & visual controls (5S), Manufacturing Standard Work, and robust training & certification programs where applicable.
• Associate Engagement promoted through the adoption of standardized problem solving methodologies, behaviour-based safety programs, and improvement idea and suggestion systems.
• Systems & Process Optimization through adoption of principles of built in quality.

Benefits

• Medical, dental, vision, disability, life insurance, and adoption benefits.
• Parental leave.
• Supplemental life insurance, critical illness, hospital indemnity and accident insurance.
• 401(k) plan with company matching contributions.
• 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: Mid Level