Apply on Employer Site

Integer Holdings Corporation · 1 day ago

Regulatory Affairs Specialist

Palm Harbor, FL

Full-time

Onsite

Entry Level

1+ years exp

Integer Holdings Corporation is committed to a culture that embraces diversity and positions the company for long-term success. The Regulatory Affairs Specialist will support the Regulatory Affairs managers by managing regulatory submissions, maintaining compliance with FDA regulations, and collaborating on quality management initiatives.

Health CareManufacturingMedicalMedical Device

Responsibilities

Provide team support to Regulatory Affairs managers and department management in being responsible for capturing, archiving, and publishing of regulatory documents

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 for product submissions and consult with multiple sources for information 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 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 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 differentiated quality

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 data as required for QA RA weekly and monthly metrics, supporting the walk to differentiated quality

Support 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 submissionsQuality Management SystemsFDA regulationsEuropean Medical Device RegulationMicrosoft OfficeWritten communicationOral communicationOrganizational skills

Required

Bachelor's degree and at least 1 year of relevant experience, or a minimum of 3 years' relevant medical device or other regulated industry experience

Ability to work independently as well as collaboratively with other associates and cross functional teams

Understanding of the European Medical Device Regulation, US FDA regulations and other applicable regulations as 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.)

Positive, can-do attitude with an underlying belief that failure is not an option

Benefits

Medical

Dental

Vision

Disability

Life insurance

Adoption benefits

Parental leave

Supplemental life insurance

Critical illness

Hospital indemnity

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

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