Senior Regulatory Affairs Specialist

Overview

Instrumentation Laboratory

Our Passion. Your Results.

Founded in 1959, Instrumentation Laboratory (IL) is a global leader in the development, manufacturing and distribution of diagnostic solutions for Acute Care Diagnostics, patient blood management and Hemostasis testing. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing medical professionals the most valuable and complete solutions to enhance patient care.

As an integral part of Werfen, a global healthcare company dedicated to delivering the highest quality in vitro diagnostic products, IL is supported by significant resources, outstanding scientific expertise and a tremendous knowledge base. IL is headquartered in Bedford, MA, USA.

Position Summary:

Responsible to lead domestic and/or international registration and renewal activities for IL-labeled products. Related duties include participation on design teams, authoring of regulatory assessments for both new products and product modifications, documentation of regulatory impact from device modifications, establishment and maintenance of Technical Files, labeling I advertising review and other regulatory work required to maintain domestic and international compliance.

Responsibilities

Key Accountabilities:

Responsible to participate on design teams (both Hemostasis and Acute Care Diagnostics) as the Regulatory representative and provide guidance on domestic and international requirements, including:

  • Author Regulatory Assessments I Plans on regulatory requirements for worldwide submissions for new products and significant post-market modifications as part of design input.
  • Author Regulatory Determinations on worldwide registration impact for significant product modifications as a design output.
  • Prepare new product registration packages and technical files (e.g. CE Mark, 510ks, Canadian licenses, CFDA registration materials, Japan Shonin information).
  • Prepare support materials for Milan Regulatory for other country registrations (e.g. Australia, Korea, Latin America).
  • Prepare product renewal packages to maintain country registrations.
  • Responsible for the updating of Technical Files to ensure compliance.
  • Responsible for maintenance of Regulatory Database in SAP.
  • Responsible to review and approve Marketing promotional materials as determined by workload.
  • Responsible to review and approve labeling and Change Orders as determined by workload.
  • Educate and train IL personnel on domestic and international country registration and labeling requirements to ensure that during product development, their requirements are understood and incorporated.
  • Other assignments related to RA/QA to support Werfen requirements and priorities
Budget managed (if applicable) N/A

Internal Networking/Key relationships:
  • To be determined based on department needs
Skills & Capabilities:
  • Proficiency with standard software (Word, Excel, PowerPoint, etc.).
  • Experience with SAP is a plus.
  • Requires superior communication skills (verbal and written)
Qualifications

Min Knowledge & Experience required for the position:
  • Requires a Bachelor degree, preferably in Life Sciences
  • Minimum of 5 years of experience in the Medical Device Industry or other highly regulated environment with experience in domestic and/or international product registrations (e.g. FDA 51 Ok, Canadian licenses, CE mark, CFDA registration)
International Mobility: Required: no

Travel requirements:
  • Must be available to travel domestically and internationally as needed


If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Instrumentation Laboratory appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V

Werfen is a global leader in in vitro diagnostics (IVD) in the specialities of Hemostasis, Acute Care Diagnostics and Autoimmunity. Our core business is dedicated to R&D, manufacturing and distribution of diagnostic systems for hospitals and clinical laboratories. Our other areas of expertise include Original Equipment Manufacturing, Clinical Software, Clinical Chemistry, Infusion Therapy, and Medical Devices and Scientific Instrumentation Distribution.

We operate directly in over 30 countries and in more than 100 territories through distributors. In 2016, our turnover was approximately 1.2 billion euros and we had an average workforce of 4,400 people. Currently, we are over 5,000 employees.

www.instrumentationlaboratory.com/


Meet Some of Instrumentation Laboratory's Employees

Christiana M.

Senior Project Coordinator

With 30 years of experience at IL, Christiana has amassed invaluable knowledge in IVD. Today, she works on the development of new products and mentors new team members.

Calvin T.

Materials Process Leader

Calvin manages the production plan for GEM Premier blood analyzers. He focuses on continuous improvement projects, such as streamlining the shipping process between IL facilities in NY and MA.


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