Sr Manager, Regulatory Affairs - Medical Devices
We're partnering with a globally renowned company specializing in clinical development, sales, and marketing of pharmaceuticals, diagnostic imaging agents, and medical devices. Currently, they seeking a Senior Manager of Regulatory Affairs with a focus on Medical Devices to join their team. This is a full-time remote position, with a preference for candidates residing or working in the EST time zone.
Responsibilities:
Lead regulatory compliance efforts for medical device products globally. Manage documentation for new regulatory filings and maintain existing submissions. Coordinate with internal teams and external manufacturers to ensure compliance with international regulations. Requirements:
Bachelor's degree in life sciences, engineering, or chemistry. Minimum 5 years of experience in medical device regulatory affairs. Expertise in US, EU, and Canadian regulatory requirements. Strong knowledge of ISO 13485 and design control regulations. Excellent communication and project management skills.
Benefits:
Competitive salary plus annual bonus, PTO, 401(k), healthcare, dental, and vision insurance. Other perks include a working culture that promotes healthy work/life balance, opportunities for advancement, and much more. If you are interested, please send an email to email protected Pay Details:
$130,000.00 to $160,000.00 per year Equal Opportunity Employer/Veterans/DisabledTo read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https:
//www.adeccousa.com/candidate-privacy />The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements. Recommended Skills Chemistry Communication Iso 13485 Project Management Regulatory Compliance Regulatory Requirements Apply to this job. Think you're the perfect candidate? Apply Now $('.external-apply-email-saved').on('click', function (event) window.ExternalApply = window.open('/interstitial?jobdid=j3t426624q9t1tc3pfv', 'ExternalApply-j3t426624q9t1tc3pfv'); ); $(document).ready( function() $(#ads-desktop-placeholder).html(
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n Estimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities:
Lead regulatory compliance efforts for medical device products globally. Manage documentation for new regulatory filings and maintain existing submissions. Coordinate with internal teams and external manufacturers to ensure compliance with international regulations. Requirements:
Bachelor's degree in life sciences, engineering, or chemistry. Minimum 5 years of experience in medical device regulatory affairs. Expertise in US, EU, and Canadian regulatory requirements. Strong knowledge of ISO 13485 and design control regulations. Excellent communication and project management skills.
Benefits:
Competitive salary plus annual bonus, PTO, 401(k), healthcare, dental, and vision insurance. Other perks include a working culture that promotes healthy work/life balance, opportunities for advancement, and much more. If you are interested, please send an email to email protected Pay Details:
$130,000.00 to $160,000.00 per year Equal Opportunity Employer/Veterans/DisabledTo read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https:
//www.adeccousa.com/candidate-privacy />The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements. Recommended Skills Chemistry Communication Iso 13485 Project Management Regulatory Compliance Regulatory Requirements Apply to this job. Think you're the perfect candidate? Apply Now $('.external-apply-email-saved').on('click', function (event) window.ExternalApply = window.open('/interstitial?jobdid=j3t426624q9t1tc3pfv', 'ExternalApply-j3t426624q9t1tc3pfv'); ); $(document).ready( function() $(#ads-desktop-placeholder).html(
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n Estimated Salary: $20 to $28 per hour based on qualifications.
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