Greiner Bio-One Americas
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Regulatory Specialist
role at
Greiner Bio-One Americas
1 day ago Be among the first 25 applicants
Responsibilities
Establish and maintain procedures for recalls, medical device reporting (MDR/MPR), and critical complaint handling.
Lead, manage, and prepare submissions for MDRs, MPRs, recalls, and Field Safety Correction Reports (FSCA).
Serve as the subject matter expert (SME) during regulatory inspections and audits.
Develop and maintain strong relationships with internal teams, external stakeholders, and key opinion leaders (KOLs).
Ensure timely and accurate submissions to regulatory authorities.
Prepare customer notifications, communications, and documentation related to field corrections. Maintain essential records for regulatory compliance.
Coordinate customer communication mailings using internal and third-party resources.
Collaborate with GBO sites and regulatory professionals per company procedures.
Interface directly with the FDA, Health Canada, and other regulatory bodies on recalls, MDRs, MPRs, and vigilance reporting.
Manage mandatory corrections, removals, and recalls efficiently and effectively.
Drive investigations and responses for critical complaints with cross-functional teams.
Perform statistical evaluations and prepare trending reports and summaries to identify potential systemic issues.
Perform additional duties as assigned.
Your Profile
5-8 years of experience in the life sciences industry, preferably in medical devices.
Bachelor’s degree in a scientific or healthcare-related field (preferred).
Proven experience in executing medical device recalls, MDR submissions, and critical complaint handling.
Strong technical writing skills for regulatory or government submissions.
In-depth knowledge of FDA regulations (21 CFR Parts 803, 806, 820, 830) and ISO standards (13485, 14971).
Demonstrated ability to interact with regulatory authorities (FDA, Health Canada, etc.) via written and in-person communications.
Hands-on experience with FDA eSubmitter and FDA ESG systems.
Our Offer Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Legal
Industries
Medical Equipment Manufacturing
Referrals increase your chances of interviewing at Greiner Bio-One Americas by 2x
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Regulatory Specialist
role at
Greiner Bio-One Americas
1 day ago Be among the first 25 applicants
Responsibilities
Establish and maintain procedures for recalls, medical device reporting (MDR/MPR), and critical complaint handling.
Lead, manage, and prepare submissions for MDRs, MPRs, recalls, and Field Safety Correction Reports (FSCA).
Serve as the subject matter expert (SME) during regulatory inspections and audits.
Develop and maintain strong relationships with internal teams, external stakeholders, and key opinion leaders (KOLs).
Ensure timely and accurate submissions to regulatory authorities.
Prepare customer notifications, communications, and documentation related to field corrections. Maintain essential records for regulatory compliance.
Coordinate customer communication mailings using internal and third-party resources.
Collaborate with GBO sites and regulatory professionals per company procedures.
Interface directly with the FDA, Health Canada, and other regulatory bodies on recalls, MDRs, MPRs, and vigilance reporting.
Manage mandatory corrections, removals, and recalls efficiently and effectively.
Drive investigations and responses for critical complaints with cross-functional teams.
Perform statistical evaluations and prepare trending reports and summaries to identify potential systemic issues.
Perform additional duties as assigned.
Your Profile
5-8 years of experience in the life sciences industry, preferably in medical devices.
Bachelor’s degree in a scientific or healthcare-related field (preferred).
Proven experience in executing medical device recalls, MDR submissions, and critical complaint handling.
Strong technical writing skills for regulatory or government submissions.
In-depth knowledge of FDA regulations (21 CFR Parts 803, 806, 820, 830) and ISO standards (13485, 14971).
Demonstrated ability to interact with regulatory authorities (FDA, Health Canada, etc.) via written and in-person communications.
Hands-on experience with FDA eSubmitter and FDA ESG systems.
Our Offer Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Legal
Industries
Medical Equipment Manufacturing
Referrals increase your chances of interviewing at Greiner Bio-One Americas by 2x
#J-18808-Ljbffr