An employer is seeking multiple Remote Regulatory Affairs Specialists for a two year project with extensions. These Regulatory Affairs specialist must have excellent documentation skills and must be able to be a self-manage/motivate as the contract will remain remote throughout its entirety. The role will be in support of the current MDR submissions impacting the entire medical device industry. Prior knowledge of MDR, FDA, NDA, or 510k regulations is a plus, but would allow for a candidate to hit the ground running. Within this role the team is looking for candidates that can support the entire lifecycle of the regulatory affairs process across multiple teams and products at a given time. Some experience working within PLM systems is required and knowledge of Windchill or Adaptiv would be a major benefit. A background within a regulated environment including FDA and ISO standards will set a candidate up for success as well. Daily responsibilities within this role will be managing the technical documentation, working with cross functional teams and for one of the candidates working closely within the labeling and IFU (instructions for use) space. Prior experience with data management will also be required for the labeling team member! Other countries that the RA specialist will work with include and are not limited to China, India. Brazil, Argentina, Mexico and Russia
2-5 years of experience in a regulatory environment (510k submissions)
Degree in Science or Engineering
MDR, NDA, or FDA background
Advanced Excel skills
PLM system experience (Windchill or Adaptiv would be preferred)
Labeling or IFU experience (only needed for a lead role)
J&J experience
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.