Henry Schein
Overview
Employer Industry: Medical Device Manufacturing
Why consider this job opportunity
Salary up to $84,992
Eligible for bonus/incentive not reflected in the posted range
Comprehensive benefits package including Medical, Dental, and Vision Coverage, 401K Plan with Company Match, and Paid Parental Leave
Opportunities for professional development and educational benefits
Supportive work environment with a focus on compliance and regulatory excellence
Minimal travel requirements (typically less than 10%)
What to Expect (Job Responsibilities)
Research and analyze laws and regulations to ensure ongoing compliance with Federal, State, and local requirements
Initiate and maintain medical device product registrations globally, focusing on international markets
Provide regulatory input to product lifecycle planning and assist in SOP development
Compile, prepare, review, and submit regulatory submissions to authorities
Monitor applications under regulatory review and provide support during inspections
What is Required (Qualifications)
2-4 years of experience in medical device manufacturing or regulatory submissions
Experience with FDA pre-market submissions preferred
Good understanding of industry practices and regulatory requirements
Strong verbal and written communication skills
Basic planning, organizational skills, and decision-making abilities
How to Stand Out (Preferred Qualifications)
Experience with ISO 13485 and EU MDR preferred
Good presentation and public speaking skills
Basic conflict resolution skills
Developing professional credibility
Experience in product recalls and recall communications
#MedicalDevices #RegulatoryCompliance #CareerOpportunity #CompetitivePay #ProfessionalDevelopment
We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately.
We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer.
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Why consider this job opportunity
Salary up to $84,992
Eligible for bonus/incentive not reflected in the posted range
Comprehensive benefits package including Medical, Dental, and Vision Coverage, 401K Plan with Company Match, and Paid Parental Leave
Opportunities for professional development and educational benefits
Supportive work environment with a focus on compliance and regulatory excellence
Minimal travel requirements (typically less than 10%)
What to Expect (Job Responsibilities)
Research and analyze laws and regulations to ensure ongoing compliance with Federal, State, and local requirements
Initiate and maintain medical device product registrations globally, focusing on international markets
Provide regulatory input to product lifecycle planning and assist in SOP development
Compile, prepare, review, and submit regulatory submissions to authorities
Monitor applications under regulatory review and provide support during inspections
What is Required (Qualifications)
2-4 years of experience in medical device manufacturing or regulatory submissions
Experience with FDA pre-market submissions preferred
Good understanding of industry practices and regulatory requirements
Strong verbal and written communication skills
Basic planning, organizational skills, and decision-making abilities
How to Stand Out (Preferred Qualifications)
Experience with ISO 13485 and EU MDR preferred
Good presentation and public speaking skills
Basic conflict resolution skills
Developing professional credibility
Experience in product recalls and recall communications
#MedicalDevices #RegulatoryCompliance #CareerOpportunity #CompetitivePay #ProfessionalDevelopment
We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately.
We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer.
#J-18808-Ljbffr