Regulatory Affairs Specialist III

Integer Holdings Corporation • Plymouth, MN

2d

About The Position

By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success. At Integer, our values are embedded in everything we do. Customer We focus on our customers’ success Innovation We create better solutions Collaboration We create success together Inclusion We always interact with others respectfully Candor We are open and honest with one another Integrity We do the right things and do things right Who are we? Integer is a global organization providing innovative, high-quality technologies and manufacturing to Medical Device OEM’s (original equipment manufacturers) to enhance the lives of patients worldwide and a provider of high-end niche batteries for specialized applications in the energy, military, and environmental markets. We are guided by our six Values, including focus on Customers, Innovation, Collaboration, Inclusion, Candor, and Integrity. Working at Integer means you are part of a team passionately pursuing excellence in all that we do and always reaching for the next great achievement. What you’ll do in this role: 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. Regulatory Submissions/Approvals 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 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. Project Support 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. Customer Support 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. External and Internal Audits 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. Quality System Responsibilities 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. Manufacturing Excellence Imperatives 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,

Requirements

• Preferably, you have earned, as a minimum, a bachelor’s degree and have at least 3 years of relevant experience. Candidates who do not meet the education requirement may be considered if they have a minimum of 5 years’ relevant medical device or other regulated industry experience.
• 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.

Nice To Haves

• Preferably, you possess a 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.”
• Assure 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.
• 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

• Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success.
• Our compensation program includes base salary and a cash-based incentive program supporting our pay-for-performance philosophy.
• We provide a 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.
• We provide 80 hours (10 days) of company designated holidays per year plus an annual allotment of paid time off.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees