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Integer Holdings Corporation · 1 day ago

Regulatory Affairs Specialist III

Plymouth, MN

Full-time

Onsite

Mid Level

3+ years exp

Integer Holdings Corporation is a global organization providing innovative technologies and manufacturing to Medical Device OEM’s. The Regulatory Affairs Specialist III will support Regulatory Affairs managers in ensuring compliance with regulations, prepare submissions for product registrations, and maintain regulatory files and reports.

Health CareManufacturingMedicalMedical Device

Responsibilities

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 embed Quality within the Regulatory discipline – 'I own Quality.' You are 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

You may 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

Qualification

Regulatory submissionsFDA regulationsQuality Management SystemsEuropean Union Medical Device RegulationLead auditor qualificationMicrosoft OfficeWritten communicationOral communicationProject managementTeam collaboration

Required

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.)

You possess a positive, can-do attitude with an underlying belief that failure is not an option

Preferred

You have earned, as a minimum, a bachelor's degree and have at least 3 years of relevant experience

You possess a lead auditor qualification

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

Company

Integer Holdings Corporation

Integer Holdings Corporation (NYSE: ITGR) is one of the largest medical device contract development and manufacturing organizations (CDMO) in the world, serving the cardiac rhythm management, neuromodulation, and cardio and vascular markets.

Founded in 2000

Wilmington, Massachusetts, USA

10001+ employees