Senior Regulatory Affairs Specialist

JobgetherColorado, CO
2dRemote

About The Position

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Regulatory Affairs Specialist - REMOTE. In this role, you will be part of a global team focused on ensuring regulatory compliance for innovative healthcare products that impact the lives of millions. You will support the regulatory planning and strategy for the development and launch of new products while collaborating closely with design and marketing teams. Your expertise will help steer product development in accordance with global regulations, enabling our partner's products to reach the market successfully and in compliance with all necessary standards.

Requirements

  • Bachelor's or Master’s degree in relevant fields such as Chemistry, Biomedical Engineering, or Law.
  • 2+ years of experience in regulatory affairs or compliance for medical devices.
  • Understanding of cosmetic formulation chemistry and global regulations.
  • Strong analytical, project management, and stakeholder communication skills.

Nice To Haves

  • RAPS RAC certification is a plus.

Responsibilities

  • Assist with the implementation of global regulatory roadmaps and marketing strategies.
  • Advise product design teams on regulatory strategy for new products.
  • Plan regulatory compliance for new product introductions and changes.
  • Support development of regulatory plans and risk assessments for product registrations.
  • Facilitate regulatory submissions and identify potential approval risks.

Benefits

  • Competitive salary and potential annual incentive bonus.
  • Generous paid time off (PTO) policies.
  • 401(k) plan with company matching up to 7%.
  • Health Savings Account (HSA) with company contribution.
  • Stock purchase plan and education reimbursement opportunities.
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