Immucor Quality Jobs

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Immucor, Inc. Regulatory Affairs Manager in Warren, New Jersey

Overview

Founded in 1982 and based in Norcross, GA, Immucor is a global leader in transfusion and transplantation diagnostics products 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 patients in need of a transfusion or transplant. Our new corporate identity illustrates the right match of donors with patients in need of blood or a specific 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 Manager to join our Regulatory Affairs team. This person will be responsible for leading our domestic and international regulatory approval to market devices in accordance with applicable US Federal Regulations. If you’ve got the necessary skills and experience to excel in this position, we want to hear from you. Apply today!

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 .

Regulatory Affairs Manager (Quality, Regulations, Medical Devices)

Responsibilities

Manages activities and provides leadership for staff associated with regulatory approval of IVD biological products and medical devices. Responsible for activities which lead to and maintain both domestic and international regulatory approval to market devices in accordance with applicable US Federal Regulations, Regulation EU 2017/746, EN ISO 13485 standards and Immucor's Quality requirements. Responsible for assessment of product, facility and quality system changes for regulatory impact.

Other responsibilities of the Regulatory Affairs Specialist include:

  • Participate on product devlopment core teams as regulatory representative.

  • Lead complex regulatory submissions.

  • Provide regulatory support on project teams.

  • Develop and track quality metrics for RA department.

  • Review design, product, production, facility, utilities, promotional material, labeling, and software change orders for regulatory impact and domestic and international reporting requirements. Develop regulatory strategies for implementation.

  • Provide regulatory requirements and assist with the development of regulatory strategies for product development and regulatory approvals.

  • Coordinate preparation, review and submission of product applications for new and current market authorizations: 510(k), BLA, Health Canada, CE mark, and other foreign equivalents. Coordinate development of responses to deficiencies and/or questions related to regulatory submissions.

  • Responsible for maintenance of product technical files and for ongoing activities related to compliance with GlobalRegulatory directives and regulations.

  • Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic and discipline as relevant to assigned projects.

  • Evaluate CAPA and complaint data to determine the need for medical event reporting, field action or biological product deviation reporting. Manage MDR and BPD reporting.

  • Participates in inspection readiness activities

Regulatory Affairs Manager (Quality, Regulations, Medical Devices) s

Qualifications

As a Regulatory Affairs Manager, you must have strong organizational skills and experience working with cross-functional teams from diverse disciplines. You must have the ability to read, understand and retain extensive working knowledge of procedures and company documents.

Other requirements include:

  • Life Sciences degree or equivalent.

  • Minimum 5 years experience in a similar position in Quality/ Regulatory in a regulated Industry (FDA, ISO 13485, IVDD, IVDR).

  • Regulatory Affairs Certification, (RAC), desired

  • Intermediate MS Office computer skills.

  • Excellent written and verbal communications skills.

  • Strong consultative and interpersonal skills. Ability to prioritize and multi-task. Strong attention to detail and ability to summarize and communicate at all levels of the organization.

  • Team player (displays enthusiasm, confidence & commitment).

  • Exceptional communication ability (verbal & written).

  • Strong presentation skills.

  • Ability to take initiatives and work independently.

  • Strong problem solving and analytical skills.

  • Facilitation and Leadership skills.

Regulatory Affairs Manager (Quality, Regulations, Medical Devices)

IMMUCOR, INC IS AN EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER; MINORITIES/FEMALES/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.

Immucor offers a comprehensive benefits package available on the start date of your employment, including:

  • Medical, prescription, dental, and vision insurance – we offer multiple plan options so you can determine which best suits your needs and the needs of your dependents

  • Wellness program

  • STD/LTD/Life insurance all 100% company paid

  • Voluntary life/accident/hospital indemnity insurance for yourself, spouse/domestic partner and dependents

  • Tuition reimbursement

  • Company matched 401k plan

  • Vacation/Company & Personal Holidays/Sick days

Where permitted by applicable law, must be fully vaccinated or have an approved Immucor exemption by January 18, 2022 to be considered for U.S.-based job. If not currently employed by Immucor, Inc. Proof of vaccination status will be required on first day of employment.

Job Locations US-NJ-Warren

Job ID 2021-2791

Category Quality

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