Job summary
Job post source
This job is directly from Argon Medical Devices, Inc.
Job overview
The Senior Regulatory Specialist at Argon Medical Devices, Inc. is responsible for authoring regulatory submissions and technical documentation to support international markets, ensuring compliance and managing regulatory information.
Responsibilities and impact
The role involves providing regulatory guidance, preparing European technical documentation and other OUS license applications, leading gap remediation projects, submitting filings, maintaining regulatory files, tracking document changes, reviewing labeling for compliance, and assessing product changes for regulatory impact.
Experience and skills
Candidates must have a bachelor's degree in science, math, or engineering, with over 5 years of experience in FDA regulated industries, preferably in medical devices, and knowledge of international regulatory requirements.
Company overview
Argon Medical Devices Inc. is a global manufacturer of specialty medical products, focusing on devices used in interventional procedures, vascular surgery, and oncology. They generate revenue by selling a diverse range of medical devices, including biopsy needles, drainage catheters, and vascular access products, to hospitals, clinics, and healthcare providers worldwide. Founded in 1972, Argon has a history of innovation and growth, marked by strategic acquisitions and a commitment to improving patient outcomes through high-quality, reliable medical solutions.
How to land this job
Tailor your resume to emphasize your experience in preparing regulatory submissions, especially for OUS markets, and your ability to manage technical documentation and regulatory files effectively at Argon Medical Devices, Inc.
Highlight your expertise in reviewing labeling for regulatory compliance and your knowledge of international medical device regulations, focusing on disposable devices if applicable, as these are key aspects of the Senior Regulatory Specialist role.
Apply to the Senior Regulatory Specialist position through Argon Medical Devices' corporate career site and LinkedIn, as these platforms often have the most up-to-date listings and application tracking.
Connect on LinkedIn with regulatory affairs professionals and cross-functional team members at Argon Medical Devices, Inc. Use ice breakers like commenting on recent regulatory changes impacting the medical device industry or asking about their approach to managing global submissions.
Optimize your resume for ATS by incorporating keywords from the job description such as 'regulatory submissions,' 'OUS markets,' 'labeling compliance,' 'medical device industry,' and 'cross-functional collaboration' to pass automated screenings.
Use Jennie Johnson's Power Apply feature to automate applying across multiple platforms, tailor your resume with the right keywords, and identify LinkedIn connections, allowing you to focus your energy on networking and interview preparation.
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