Candidate will start remote but will be coming on site once situation is normal
Prefer local candidates only
There is a potential for this role to be Contract to hire role
Updates from manager
- Training and on the job training will be remote
- Regulatory background will also work
- Biocompatibility or mechanical reports
- Critical thinking
- Understanding of regulated environment
- 1 – 2 yrs exp with medical devices
- Maintain registrations around the world
- Should be able to understand technical documentation
- Bio medical engineering or chemical educational background
- Should be comfortable working remote
- Will support some US and EU submissions as well
- Resourceful (fast learner)
- Some submission and writing skills needed
Regulatory Affairs Associate
The Regulatory Affairs Associate is responsible for preparing worldwide regulatory submission deliverables and obtaining and maintaining approvals necessary to market products in all desired markets. This person works closely with in-country Regulatory colleagues to prepare agency submissions and with US Regulatory colleagues and other functional areas to provide timely responses to regulator questions in support of product approvals. Ensures all information provided for submissions is accurate, complete, and compliant to local requirements. Additionally, the Regulatory Affairs Associate is able to understand and apply regulations and standards affecting implantable medical devices.
- Reviewing documents required for submissions to US and international geographies to ensure they are appropriate for submission and meet local requirements.
- Working with Regulatory Affairs staff, engineers and technical experts to resolve potential regulatory issues, deficiencies and questions from regulatory agencies.
- Reviewing and approving design, labeling or manufacturing changes for implantable medical devices and preparing necessary regulatory documents to support changes.
- Providing direct temporary help in heavy work situations.
- Other duties as assigned.
BS in an engineering or scientific discipline and 1+ years of experience in a medical device or similarly regulated industry.
- Regulatory Affairs experience
- Understanding of engineering concepts and medical device development
- Experience working with technical documentation
- Strong communication skills (written and verbal)
- Proven success managing multiple projects and priorities
- Attention to detail
- Ability to work with various cultures and personality types
- Proficient in Microsoft Word, Excel, and PowerPoint