Senior Regulatory Affair Specialist - Remote

Our client in Ottawa West is currently looking for a Senior Regulatory Affair Specialist (Advertising and Promotion) to join their team. 

More about a company:

This is a worldwide leader in providing with-patient care solutions that are intuitive, reliable, and cost-effective for our customers. By delivering lab-quality results in minutes, our i-STAT® System family of with-patient products and services fosters a collaborative, patient-centered environment while driving operational performance. 

Status: Full-Time (Monday – Friday, 8:00am to 5:00pm)

Position Overview:

The Senior Regulatory Affair Specialist (Advertising and Promotion) is to provide support for the regulatory department to ensure efficient and compliant business processes and environment.  The individual may execute tasks and play a consultative role by partnering across business functions. The individual may assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of products worldwide. The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation.

Responsibilities:

  • The Senior Specialist Regulatory Affairs, Advertising & Promotions is responsible for reviewing medical education and commercial advertising and promotional materials for product, disease state, and training/education programs.
  • Responsible for timely and accurate review of all advertising and promotional materials.
  • Ensure that reviewed promotional materials are (i) accurate, truthful and not misleading, (ii) presented in a fair and balanced manner, (iii) consistent with applicable product labeling, (iv) well-substantiated by current and scientifically valid evidence, (v) adherent to applicable advertising and promotion standards, and (vi) comply with all internal and external policies and procedures
  • Evaluate FDA guidance documents, policies and the overall regulatory environment and be able to assess and communicate potential risk and impact.
  • Ensure compliance with FDA advertising and promotional regulations and guidelines for select product, disease state, and all medical education materials.
  • Ensure communications and promotional claims are in compliance with terms of approved global product registrations, applicable laws, internal policies and external regulations.
  • Evaluate global regulations regarding advertising and promotion; ensure compliance.
  • Continually assesses advertising and promotion-related processes and procedures to enhance efficiencies and compliance and recommend/implement policy and/or process changes as needed.
  • Work independently and recognize when issues need to be elevated to management.
  • Participate in regulatory intelligence gathering activities and maintain knowledge of US, Health Canada, EU and ROW regulatory requirements
  • Develop and update training resources on materials review process
  • Serve as primary point of contact and RA representative for all matters related to advertising and promotion of products.
  • Collaborate with marketing operations on prioritization for routine approvals as well as during major events and campaign launches.
  • Review and approve non-promotional items such internal training documents and internal communications
  • Provide regulatory technical support and supplement leadership and guidance to the marketing team during the development, review and approval of product advertising materials
  • Mentor other regulatory professionals.
  • Required Education and Experience:

  • Bachelor’s degree in a technical discipline (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology, math, engineering, or medical field)
  • Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
  • 5 years’ work experience with at least 3 years in Regulatory.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Experience with IVDs
  • Exposure to ISO 13485
  • Compensation will be determined based on your skills and experience.

    If you consider yourself a fit, please click on "Apply Now"

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