Senior Specialist Regulatory Affairs
My client, a global medical device company focusing on advancing emergency care and increasing clinical and operational efficiency, is looking to add a Senior Specialist to their Regulatory team.
The Senior Specialist will be responsible for:
- Supporting in developing partnerships with program management, manufacturing, product development, quality assurance, and marketing to ensure product compliance
- Coordinating and maintaining FDA PMA and 510(k) Premarket Notifications in accordance with FDA requirements
- Working with department management to provide global regulatory strategy and regulatory plans
- Preparing and maintaining CE files in accordance with Medical Device Directive requirements
- Participating in regulatory audits/inspections as needed
The Senior Specialist should have the following qualifications:
- Bachelor's degree with 6+ years of Regulatory experience in the Medical Device Industry
- Understanding of US and European/international regulations and standards
- Experience working with the FDA
- Experience with medical device regulatory submissions (510(k) or PMA)
- Casual dress/atmosphere
If you are interested in this position, please apply today and do not hesitate to reach out with any questions!