Regulatory Affairs Document Writer
1 week ago
We are seeking an experienced Regulatory Affairs Document Writer to join our team at Lifelancer. This is a full-time opportunity that offers a competitive salary and benefits package.
About the Role:As a Regulatory Affairs Document Writer, you will be responsible for preparing and submitting high-quality regulatory documents to regulatory agencies and health authorities. You will work closely with cross-functional teams to develop global regulatory programs and product development projects.
Key Responsibilities:- Prepare and submit regulatory documents such as 510(k)s, Pre-Market Approval (PMA) submissions, and EU Technical Documentation Files.
- Provide support for the preparation and submission of critical regulatory documents and responses to health authority information requests.
- Collaborate with project teams and functional area contributors to advance global regulatory programs and product development projects.
- 4-8 years of experience in a related field, such as medical writing or regulatory affairs.
- Excellent scientific writing skills and experience performing literature reviews and analyzing data.
- Proven ability to build positive relationships with cross-functional teams and communicate effectively with stakeholders.
The estimated salary range for this role is $93,500-$133,600 per year, depending on location and experience. Cardinal Health offers a comprehensive benefits package, including medical, dental, and vision coverage, paid time off, and retirement savings plans.
What We Offer:- A dynamic and supportive work environment.
- Ongoing training and professional development opportunities.
- A commitment to diversity, equity, and inclusion.
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