Medical Writer (Regulatory submission) in North Chicago, IL

Regulatory Submission Writer 

• Ivd or medical device or pharma experience
• Proofreading on the submission
• author the submission is plus
• Working with cross-functional team
• Regulatory submission
• Product labelling
• Looking for regulatory background
• Ivdr submission, Pma, 510k submission
• Regulatory submission writing

• The company is seeking candidates for a position in regulatory submission writing, distinct from general medical or technical writing roles.
• The main requirement is experience in regulatory submissions, specifically related to IVDR in the EU or FDA submissions in the US, such as PMA, BLA, or 510 submissions.
• Candidates with experience limited to promotional, web-based content, e-learning materials, or job aids are not suitable for this role.
• A background in editing or proofing regulatory submissions is acceptable, though the ability to write these documents is preferred.

• While a degree in life sciences is not required, relevant experience in regulatory writing is critical.
• Applicants from diverse educational backgrounds, including journalism or English, are welcome, as long as they can effectively communicate complex information to the FDA.
• The position demands a minimum of five years of industry experience in regulatory writing. This role is not intended for individuals with only academic exposure to regulatory affairs.

• The role is within the transfusion medicine organization, which deals with blood screening products. While specific product experience in blood screening isn't necessary due to its niche market, a background in in vitro diagnostics, medical devices, or pharmaceuticals is advantageous.
• This is an on-site role based in Lake County, Chicago, with no option for hybrid or work. Although the job description mentions the possibility of up to 5% international travel, it is unlikely for contractors.

Rangam Consultants is a minority, women-owned, disability workforce solutions global organization. We specialize in attracting and retaining talent globally for rewarding careers in IT, Engineering, Scientific, Clinical, Healthcare, Administrative, Finance, Business Management, and many more, while integrating veterans and individuals with disabilities into the workforce. Indeed, we connect career aspirants to relevant job opportunities, whether in the USA, UK, India, or Ireland. Additionally, we offer Location Independent jobs and contract positions across different verticals and industries.
Rangam strives to put job seekers first, providing them with free access to search for jobs, post resumes, and research companies. Every day, we connect millions of people to new opportunities.