Regulatory Affairs Expert

6 days ago


Lake Forest, Illinois, United States Collabera Full time

We are seeking a highly skilled Regulatory Affairs Expert to join our team at Collabera, a Global Digital Solutions Company.

Job Overview

Collabera is a leading provider of Software Engineering Solutions for the world's most tech-forward organizations in areas such as Engineering, Cloud, and Data/AI. With operations across 60 locations in 11 countries, we serve 30% of the Fortune 500 and have consistently exceeded industry growth rates.

Job Description

The successful candidate will support our Global Director Medical & Scientific Affairs in defining medical affairs strategy and conducting activities related to the IVDR process. Key responsibilities include:

  • Supporting and conducting tasks under the supervision of the Global Director Medical & Scientific Affairs;
  • Functioning as a scientific/medical liaison to key stakeholders in the IVDR core team;
  • Driving and generating medical actions to resolve medical/scientific issues related to different IVDR actions required by the team;
  • Participating in all IVDR meetings to represent Medical Affairs functions and provide support for identified medical needs;
  • Reviewing published literature and real-life evidence related to our products, analyzing, and presenting it in the required format to support the IVDR team;
  • Collaborating on planning and execution of Advisory Board Meetings or other non-promotional medical projects to provide medical evidence needed for the IVDR process;
  • Providing sound and up-to-date medical information, disease knowledge, and medical training when necessary to other business functions;
  • Driving medical scientific knowledge, reviewing medical literature, generating potential new ideas to enhance and maximize benefit for disease management and patient care;
  • Maintaining all relevant documentation for medical affairs projects and activities for compliance, including related to the IVDR process;
  • Contributing to medical education content generation for digital activities and platforms intended for patients and HCPs;
  • Identifying and overseeing establishment and maintenance of scientific collaborative relationships with Key Opinion Leaders (KOLs), accountable and responsible for KOL development, KOL engagement, and approaching KOLs for provision of services.
Requirements

To be considered for this role, candidates must possess the following qualifications:

  • M.D. degree required;
  • Good understanding and experience in conducting clinical trials or medical research in the industry or academia or equivalent;
  • Minimum 3+ years of experience in a related role in industry;
  • Experience in seeking medical information and writing medical documents;
  • Prior experience in global medical affairs roles is desirable;
  • Must have attention to detail, able to work in a team environment, good organizational skills, and multi-tasking ability;
  • Project management skills needed;
  • Strong written and verbal communication skills;
  • Strong presentation skills.
Compensation and Benefits

We offer an estimated salary of $120,000-$180,000 per year, based on location and experience. Our comprehensive benefits package includes health insurance, retirement savings plan, paid time off, and opportunities for professional growth and development.



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