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 Specialist II to join our Regulatory Affairs team. This is a great opportunity to work with every area of the organization including our International team. This is an exciting time to bring our products to market. If you have experience registering medical device, bio-tech or pharmaceutical products in the international markets (China, Korea, India, Malaysia, Canada) we would love 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 II/ Medical Device Product Registration/ International

Responsibilities

As a Regulatory Affairs Specialist II, 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:

• Prepare the following regulatory submissions: U.S. 510(k), Health Canada, European Technical Files, IVDR, and others

• Prepare technical documentation to support country registrations and renewals

• Prepare and maintain state and federal medical device establishment registration and listings

• Obtain regulatory permits, including import/export

• Provide active and ongoing regulatory guidance to site and project teams including regulatory submission strategies

• Review advertising and promotional materials for both RUO and IVD products

• Keep abreast of new or revised regulations, guidelines, points to consider, compliance guides

• Review change orders for regulatory impact and domestic and international reporting requirements

• Evaluate complaint, deviation, NCR and OOS data to determine the need for medical event reporting, field action or biological product deviation reporting

• Write and maintain departmental SOPs

• Perform MDR Assessments as part of complaint management

• Recognize and elevate critical regulatory/compliance issues to RA management

• Assist with the administration of regulatory and third-part inspections

• Oversee and perform LN regulatory control blocks and unblocks.

Regulatory Affairs Specialist II/ Medical Device Product Registration/ International

Qualifications

We are looking to hire a Regulatory Affairs Specialist who has direct previous Regulatory Affairs experience at a medical device, pharmaceutical or similar regulation industry. It is also important that you display excellent communication, interpersonal and presentation skills, as well as the desire to work in a fast-paced, team-oriented environment.

Additional requirements:

• Bachelor's degree BA/BS from four-year college or university; or equivalent combination of education and experience.

• Direct previous Regulatory Affairs experience at a medical device company, pharmaceutical or similar regulation industry required

• Minimum 2-5 years relevant experience.

• Knowledge and practice of GMP and GLP.

• Regulatory Affairs Certification (RAC), preferred

• Domestic and International Product registration experience

Regulatory Affairs Specialist II/ Medical Device Product Registration/ International

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.

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, all new hires must be fully vaccinnated agCOVID COVID-19 vaccine . Proof of vaccination status will be required on first day of employment.

Job Locations US-WI-Waukesha

Job ID 2022-3006

Category Other