Regulatory Affairs Specialist II

Job description

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. Responsibilities: Regulatory Submissions/Approvals 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. 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 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. 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 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. How you will be measured: The specific measures listed below may be subject to change and are not intended to be an all-inclusive list. Safety is our highest priority; you will be an active supporter of the Integer Environmental, Health & Safety programs. You will have defined Goals and Objectives specifying key projects and expected milestones to achieve. Achievement of site quality KPI’s Innovation and ideation are critical aspects of your role, and you will be expected to generate continuous improvement suggestions and support the implementation of them. What sets you apart: Preferably, you have earned, as a minimum, a bachelor’s degree and have at least 1 year of relevant experience. Candidates who do not meet the education requirement may be considered if they have a minimum of 3 years’ relevant medical device or other regulated industry experience. While you will have occasional support and guidance from more experienced regulatory professionals, supervisors or managers, you will demonstrate the ability to work independently as well as collaboratively with other associates and cross functional teams. You demonstrate an understanding of the European Medical Device Regulation, US FDA regulations and other applicable regulations as 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. U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply.