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Fantastic Quality Manager opportunity for a growing medical device company!
Description:
- Provide strategic input and regulatory advice to project teams and development programs including new product development and changes to existing products.
- Prepare US FDA submissions and CE Mark technical documentation files, including 510(k) submissions, Device Master files, technical files and post market surveillance for product changes and/or new products as required to ensure timely clearance or approvals.
- Lead, coordinate, author and review regulatory filing documents.
- Create and maintain regulatory submission timelines and track deliverables to ensure company goals are met.
- Manage and modify a complete and comprehensive quality management system for class I, II and higher medical devices.
Skills & Qualifications:
- Bachelor's degree within the sciences.
- Needs to have 3 to 5 years of experience managing a work flow.
- This candidate should have experience with internal/external audits, regulatory functions and technical writing.
Why work here?
- They bring a mom and pop type work environment with a corporate level budget!
- Newly renovated facility with on-going renovations.
- Work from home program after completing 90 days!
APPLY NOW!
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
