Job summary
Job post source
This job is directly from Exactech
Job overview
The Senior Regulatory Specialist at Exactech is responsible for ensuring global regulatory approvals and maintaining regulatory compliance to support the company's medical device products.
Responsibilities and impact
The role involves preparing and maintaining pre-market and post-market regulatory submissions, providing regulatory strategy and support for new product development and lifecycle projects, leading project regulatory affairs, assessing and approving post-market changes, nonconformances, deviations, and executing CAPA for regulatory processes.
Experience and skills
The position requires a Bachelor's degree, a minimum of 5 years experience with FDA/ISO medical device quality management systems, expertise in FDA pre-market submissions and international product registrations, and strong technical writing skills.
Job location and travel
The position is remote within the US.
Company overview
Exactech is a global medical device company specializing in the design, development, manufacturing, and marketing of orthopedic implant devices, related surgical instruments, and biologic materials. Founded in 1985, the company focuses on solutions for joint replacement, including hip, knee, and shoulder implants, which are used by surgeons worldwide. Exactech generates revenue through the sale of these medical devices and instruments to hospitals and surgical centers. A significant milestone in its history is its acquisition by TPG Capital in 2018, which has helped to expand its market reach and innovation capabilities.
How to land this job
Tailor your resume to emphasize your experience with FDA/ISO medical device quality management systems, particularly highlighting your role in preparing pre-market submissions like 510(k) and PMA, as well as international product registrations.
Highlight your ability to independently manage regulatory strategies for new product development, post-market lifecycle projects, and quality system updates, showcasing leadership as a project team RA lead.
Apply through multiple platforms including Exactech’s corporate career site, LinkedIn, and reputable medical device job boards to maximize your application reach.
Connect on LinkedIn with current Exactech Regulatory department professionals; start conversations by referencing recent regulatory developments in the medical device field or asking about the team’s approach to global regulatory compliance.
Optimize your resume for ATS by incorporating keywords from the job description such as 'pre-market submissions,' 'regulatory strategy,' 'FDA,' 'ISO,' and 'CAPA' to ensure your resume passes initial automated screenings.
Use Jennie Johnson’s Power Apply feature to automate tailored applications, identify the best job portals for Exactech roles, and find LinkedIn contacts, allowing you to focus your time on networking and interview preparation.
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