Senior Regulatory Affairs Specialist

Additional Job Description

The Senior RA Specialist will provide regulatory support on a range of medical devices and activities which include new product introduction, post market design changes, regulatory submissions, regulatory compliance, international submission support, commercial support, manufacturing support, compliance related activities, systems improvement, and other responsibilities aligned with global medical device regulations and the goals of the Patient Recovery business.

  • Participate in new product development/modification projects to understand registration requirements, recommend strategies based on current regulatory requirements and applicable industry standards, and establish/integrate regulatory submissions strategy into project activities
  • Create and maintain submissions (i.e. 510(k), CE marking applications, technical documentation, etc.) to obtain US regulatory clearance, European regulatory approvals, and maintain existing regulatory approvals through letter to file, renewals, change notifications, device listings, UDI submissions, etc.
  • In collaboration with International Regulatory Affairs, determine applicable registration requirements and assist with STED preparation for medical devices in countries in which products are to be registered
  • Review device labeling and marketing literature for compliance with global labeling regulations and product filings
  • Maintain regulatory systems and produce various reports as needed
  • Maintain and provide regulatory information in support of queries from customers, customs, bids, tenders, post-market surveillance related queries, government queries, etc.
  • Maintain regulatory intelligence through continuous monitoring of regulatory landscape / attending regulatory seminars and meetings
  • Participate in implementation of functional business process improvements

ESSENTIAL SKILLS:

  • Effective project management skills
  • Effective oral and written communication skills
  • Effective problem-solving skills
  • Ability to create cross-functional partnerships
  • Ability to work collaboratively in a team environment
  • Ability to apply judgment within defined parameters
  • Ability to manage multiple projects
  • Strong organizational skills
  • Deadline conscious