Regulatory Affairs Content Specialist

3 days ago


New York, New York, United States Lifelancer Full time

We are seeking a skilled Regulatory Technical Writer to join our team at Lifelancer, a talent-hiring platform in Life Sciences, Pharma and IT. As a Regulatory Technical Writer, you will play a crucial role in supporting regulatory document writing to develop the global evidence base for company development programs.

The successful candidate will be responsible for preparing, writing, editing, and reviewing high-quality regulatory documents founded in regulation and supported by science for submission to regulatory agencies and health authorities. This includes but is not limited to 510(k)s, Pre-Market Approval (PMA) submissions and PMA Supplements, EU Technical Documentation Files and Global STEDs, Pre-Submission meeting packages to agencies, responses to regulatory agency requests, annual reports.

This position requires excellent scientific writing skills, experience working within a medical device or pharmaceutical organization in a Research Development, Scientific and Medical Affairs, Clinical or Regulatory role, and experience writing scientific documents for regulatory or journal submissions. Additionally, the ideal candidate will have a proven ability to build positive constructive relationships with cross-functional team members and demonstrated high level of personal integrity, emotional intelligence, flexibility, analytical thinking and inquisitive mindset.

We offer a wide range of benefits including medical, dental and vision coverage, paid time off plan, health savings account (HSA), 401k savings plan, access to wages before pay day with myFlexPay, flexible spending accounts (FSAs), short- and long-term disability coverage, work-life resources, paid parental leave, healthy lifestyle programs.

The salary range for this position is approximately $93,500 - $133,600 per year, depending on qualifications and experience.



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