Immucor, Inc. Regulatory Affairs Specialist III in Waukesha, Wisconsin
Founded in 1982 and based in Norcross, GA, Immucor is a global leader in transfusion and transplantation diagnostics that facilitate patient/donor compatibility worldwide. Our mission is to ensure that patients in need of blood, organs, or stem cells get the right match that is safe, accessible, and affordable. The result is life changing for a patient in need of a transfusion or transplant. Our new corporate identity illustrates the right match of donors with patients in need of blood or an organ as well as Immucor’s partnership with healthcare organizations in need of innovation and productivity. With the right match, we can transform a life together.
We are seeking a Regulatory Affairs Specailist II to join our Regulatory Affairs team. If you have the necessary skills and experience to excel in this role, we want to hear from you!
This position is not eligible for sponsorship for work authorization by Immucor, Inc. Therefore, if you will requires sponsorship from us for work authorization now or in the future, we cannot consider your application at this time .
Regulatory Affairs Specialist III
As a Regulatory Affairs Specialist III, you will berequired to provide guidance to assure that all regulatory submissions and compliance matters are planned, communicated and executed per regulatory and business requirements. The position serves as a subject matter expert on various regulations and coordinates regulatory issue resolution through the use of internal resources, regulatory agencies, and external consultants as necessary. Performs tasks that support quality system compliance with US FDA Quality System Regulation, Health Canada, the IVD Directive (98/79/EC), ISO 13485, MDSAP, IVDR, ISO 14971, and other applicable international medical device regulations.
Additional responsibilities include:
Prepares or supports regulatory submissions; 510(k) submissions, Technical File Submissions, Health Canada licenses/submissions or their equivalent in other foreign markets. Coordinate development of responses to deficiencies and/or questions related to regulatory submissions.
Performs annual updates/renewals for FDA and Health Canada. Performs and updates FDA Medical Device Listings.
Recognize and elevate critical regulatory/compliance issues to QA/RA Management. Works to resolve issues to prevent negative regulatory impacts.
Reviews and approves quality system documents to determine compliance with SOPs, quality system and regulatory compliance and industry standards. Writes and maintains department procedures. Proactively works to identify revisions to prevent negative regulatory impacts.
Provides support to distributor’s efforts to register products when the distributor is responsible for registration. Responsible for communications to and from distributors regarding regulatory matters.
Maintains regulatory filings/information in support of international registrations.
Provide written correspondence to regulatory agency inspection finding and inquiries. Track implementation of quality system improvements and commitments to regulatory agencies.
Reviews/Approves significant changes which may have regulatory impact and/or regulatory reporting requirements (eg facility, product, process, labeling).
Participates in recall/notification process and may coordinate the activities in the event the Director QA/RA or QA Manager are not available to perform these duties. Prepares/supports regulatory notifications, status reports and effectiveness checks.
Performs internal audits as assigned. Responsible for informing the Director QA/RA or QA Manager of any deviations detected during the audit process that suggest the need for corrective or preventive action.
Can act as representative at audits with FDA, Notified Body, OSHA, and other external auditors. Has the authority to communicate with Regulatory Agencies and Associations as a liaison of Immucor GTI Diagnostics.
Evaluates complaints, internal deviations and OOS data and determines need for regulatory reporting.
Participates in Customer Complaints Review and is responsible for determining if Regulatory Reporting is required (MDRs).
Participates on product lifecycle teams and provides regulatory support. Follows Product Development Process (PDP) for applicable design activities. Reviews Design History files with Director of R&D to approve product for IVD regulatory status according to various regions (i.e. FDA, EU, Canada, etc.).
Participates in CAPA Review Board, Change Control Board and Materials Review Board.
Develops and tracks quality metrics for RA department. Provides Quality Assurance Metrics for Regulatory activities to QA to use as part of QRB and Management Review.
Maintains current versions of ISO standards, CLSI Guidances and other regulations.
Completes training and development assignments prior to due dates.
Regulatory Affairs Specialist III
Master’s degree (MA) or equivalent with four to ten years related experience and/to training; or equivalent combination of education and experience.
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
Ability to apply mathematical operations to such tasks frequency distribution, determination of the test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Ability to read, analyze and interpret common scientific and technical journals, financial reports and legal documents.
Ability to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community.
Ability to write speeches and articles for and articles for publication that conform to prescribed style and format.
Ability effectively present information to top management, public groups and/or boards of directors.
Regulatory Affairs Specialist III
IMMUCOR, INC IS AN EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER; MINORITY/FEMALE/DISABLED/VETS; DRUG FREE WORKPLACE
RESUMES SUBMITTED TO IMMUCOR FROM THIRD PARTY RECRUITMENT FIRMS WILL NOT BE CONSIDERED.
This position is not eligible for sponsorship for work authorization by Immucor, Inc. Therefore, if you will require sponsorship from us for work authorization now or in the future, we cannot consider your application at this time.
Job Locations US-WI-Waukesha
Job ID 2021-2530