This position is part of the Project Management group and will help manage medical device labeling projects in addition to other related projects.
General Description and Duties:
This position will coordinate workflow of various R&D, Operations and Regulatory projects. The job responsibilities include the following:
- Co-ordinate various projects working closely with Regulatory Affairs, R&D, Marketing and Operations teams
- Create project related documentation to meet internal and regulatory agencies requirements
- Co-ordinate with external vendors and internal teams with respect to supply chain issues, parts delivery, and implementation timelines
- Schedule and conduct change reviews
- Participate in risk management activities to address labeling changes
- Review and approve changes including but not limited to drawings, labeling, translations etc.
- Support inventory management
- Ensure compliance with Quality System Regulations
- Establish and maintain team member and project stakeholder relationships, expectations, and communications.
- Manage external vendors and services, as needed for the project.
- Bachelor's degree in engineering/sciences.
- Working knowledge of FDA medical device quality system regulations
- Proficient in English language.
- Excellent communication, both written and verbal, skills
- Demonstrates ability to work in a highly cross functional and global environment
- Self-motivated with strong focus on details and accuracy.
- Able to work in fast paced environment
- 1 year of project coordinator experience
- 1 years of Medical Device industry experience in R&D, Operations or Regulatory function
- Experience with project management tools such as MS Project
- Experienced in gathering and tracking metrics
Aligning our overall business objectives with performance and merit based pay, Axonics offers competitive salaries, performance-based incentives, and Employer paid benefits programs to address the diverse individual needs of our employees and their families. At Axonics, our employees come first!
For California, the base pay range for this position is $65,000 to $80,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).
Axonics is an Equal Opportunity Employer, included protected Veterans and individuals with disabilities.