Do you have experience in Regulatory Affairs, specifically related to implantable Medical Devices? PaxMed International is seeking a person with 3+
The Regulatory Specialist will be a key member of the PaxMed International team, responsible for the development of regulatory submissions for our clients, who are medical device companies.
This position is based in the Carmel Valley area of San Diego, CA.
- Development of regulatory submissions, assisting with regulatory strategy
- Interacting with our clients to collect and organize the required information needed for submissions
- Managing the project to ensure efficient and timely completion.
- Requires hands-on experience with medical device regulatory submissions, preferably in the dental and orthopedic implant space
- If your experience with submissions is limited, but you have extensive experience with dental implants, especially CAD/CAM processes for dental implant abutments, we may consider you if you also are a skilled writer and are highly motivated to learn regulatory submissions.
- Excellent leadership, organizational, written and oral communication skills.
- Highly self-motivated and able to work effectively with minimum supervision.
- Demonstrate proficiency at building consensus when working within a team setting.
- Must be familiar with the laws, regulations, standards and guidance governing the 510(k), IDE and PMA processes, as well as European regulations, including Technical Files and Design Dossiers.
- Working knowledge of other international regulatory requirements is a plus. Experience with Quality Systems in the medical device industry is another plus.
If you feel you meet our qualifications, please email Jim Duvall (firstname.lastname@example.org) and include your resume, contact information, and best time(s) to speak with you.