732-661-0400

Regulatory Affairs Specialist

  • Location: Milwaukee, WI
  • Type: Direct Hire
  • Job #36761

Overview

Founded in 1982 and based in Norcross, GA, our client 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 our clients 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 and Commercial team. This is an exciting time to bring our products to market. You will have an opportunity to work with a great team. 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!

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.

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

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Equal Employment Opportunity (EEO) Information

While the position you're applying for may not be for a government role, Astrix is a governmental contractor and, as such, is required to collect certain information in its applicants. Astrix is an Equal Opportunity Employer and does not discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status. Completion of these fields will not affect your opportunity for employment or the terms or conditions of your employment.

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