Job summary
Job post source
This job is from a recruiting firm hiring for a separate company, as the company name ACE Partners suggests a recruiting or consulting firm rather than a direct employer.
Job overview
The Regulatory Specialist role involves managing regulatory compliance related to recalls, medical device reports, and complaints to ensure adherence to FDA, ISO, and global standards, impacting product safety and regulatory standing.
Responsibilities and impact
The specialist will develop procedures for recalls and complaint handling, lead regulatory submissions, act as a subject matter expert during audits, communicate with stakeholders, support regulatory authority interactions, oversee corrections and recalls, and perform investigations and trend analysis on complaints.
Experience and skills
Candidates should have 5-8 years in life sciences, preferably medical devices, a bachelor's in a scientific or healthcare field preferred, expertise in medical device recalls and regulatory submissions, familiarity with FDA regulations and ISO standards, and experience with FDA eSubmitter and ESG platforms.
Company overview
ACE Partners is a global management consulting firm specializing in strategy, operations, and digital transformation. They generate revenue by providing expert advisory services to businesses across various industries, helping clients improve performance and achieve sustainable growth. Founded in the early 2000s, ACE Partners has built a reputation for delivering innovative solutions and fostering long-term client relationships. Their notable history includes successful projects with Fortune 500 companies and a commitment to thought leadership through published research and industry insights.
How to land this job
Tailor your resume to highlight your expertise in managing medical device recalls, MDRs, and complaint handling, emphasizing your knowledge of FDA regulations like 21 CFR 803, 806, 820, and 830, as well as ISO standards such as 13485 and 14971.
Showcase your experience with regulatory submissions, particularly your proficiency in using FDA eSubmitter and ESG platforms, and your ability to lead audits and inspections as a subject matter expert.
Apply through multiple channels including ACE Partners' corporate careers page and LinkedIn to maximize your application visibility and ensure your resume reaches the right hiring managers.
Connect on LinkedIn with professionals in ACE Partners' regulatory or quality assurance divisions; break the ice by referencing recent regulatory changes or asking about their approach to compliance challenges in medical devices.
Optimize your resume for ATS by incorporating keywords from the job description like 'regulatory submissions,' 'medical device recalls,' 'FDA eSubmitter,' 'ISO 13485,' and 'complaint handling' to improve your chances of passing initial screenings.
Use Jennie Johnson's Power Apply feature to automate tailored resume customization, multi-channel application submissions, and LinkedIn networking outreach, freeing up your time to focus on interview preparation and deeper research.
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