Regulatory Operations Lead

Junto HLS has been engaged by a top healthcare company in Northern New Jersey to recruit a Regulatory Operations Lead to work across a number of market leading products/projects, many of which you’d be familiar with as both a professional and a consumer.

Why Consider:  

  • A Rising Tide – Build your career in a company which continues to expand its business, creating new and engaging growth opportunities for its people
  • Career Development – Work with Sr. Regulatory Leadership with a demonstrated track record of people development
  • A Strong Team – Join a high integrity, high functioning team of peers, mentors/managers and cross-function stakeholders you can respect and learn from
  • Market Leading – Work on market leading brands you’d know as both a consumer and professional, in a company positioned to become the #1 in its sector within the US
  • Best of Both Worlds – Join a business with the scale, global reach and power brands of a large business while working in an entrepreneurial, low bureaucracy and action oriented team environment
  • Expand Your Skillset – With a diverse set of products and responsibilities, you’ll be sure to build knowledge and experience in new areas

 

Position Overview:  

  • BA/BS degree required
  • High attention to detail and strong organization skills
  • Results oriented, entrepreneurial and self-motivated
  • Provide Regulatory support for current products and development projects
    • Execute strategy and provide regulatory support and input.  Deliver projects and other initiatives to progress current product portfolio by providing regulatory direction and support to stakeholders
    • Collect and collate data required for regulatory support of FDA cosmetics, OTC drugs and medical devices (510(k)).
    • Prepare dossiers and submission packages to comply with relevant FDA requirements for product launches.
  • Correspond with the appropriate Federal or State Agency regarding registration submissions.
  • Review product labeling and supporting materials.
  • Keep current with all relevant guidelines and regulations and work with stakeholders to implement new regulations and guidelines
  • Support infrastructure and systems integration
  • Monitor and gain an understanding of new policies and objectives involving federal and local government affairs.

Location(s):

  • Northern New Jersey

If you are open to explore and learn more about this opportunity submit your resume using the button below or send directly to Michelle@juntoHLS.com.