Nordberg Medical
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The Regulatory Affairs Specialist US is responsible for preparing, reviewing, and maintaining regulatory submissions and documentation required for U.S. FDA approvals of high‑risk and Class III implantable medical devices, including degradable and bioabsorbable implants. The role focuses on ensuring compliance with FDA regulations and supporting product lifecycle management from development to post‑market activities, collaborating closely with global Regulatory Affairs colleagues and cross‑functional teams.
Key Responsibilities
Prepare, review, and submit U.S. regulatory documentation, including Investigational Device Exemptions (IDE), Premarket Approval Applications (PMA), PMA Supplements, and 510(k) submissions.
Evaluate and confirm completeness and accuracy of technical and clinical documentation to support U.S. registrations.
Collaborate with global RA colleagues to align submission strategies and documentation.
Support discussions with CROs, external consultants, and FDA representatives, leveraging internal and external networks.
Review labeling, IFUs, and promotional materials for compliance with U.S. regulations.
Ensure regulatory compliance with FDA 21 CFR 807, 812, 814 and applicable guidance for PMA and 510(k) submissions.
Participate in audits and FDA inspections as a Regulatory Affairs subject matter expert.
Monitor changes in U.S. regulatory requirements and assess potential impact on products and documentation.
Maintain accurate regulatory records and tracking systems in compliance with ISO 13485 and internal quality system procedures.
Skills and Requirements Education:
Bachelor’s degree in Regulatory Affairs, Biology, Biomedical Engineering, Life Sciences, or related field.
Experience:
About 3–5 years of regulatory affairs experience in the medical device industry, specifically working with degradable implants. Preferred experience in aesthetics injectables or orthopedics. Must have prepared, reviewed, and submitted regulatory documentation and responded to FDA inquiries, used regulatory information management systems or submission tools, and worked with CROs or external partners for regulatory submissions.
Knowledge:
Strong understanding of U.S. FDA regulatory pathways, including PMA or 510(k) processes. Familiarity with ISO 13485, ISO 14971, and FDA Quality System Regulations (QSR).
Personality:
Adaptable and growth‑minded, detail‑oriented and structured, collaborative communicator, independent and proactive, capable of managing work with minimal supervision, including in a remote setting.
Other Information:
This is a full‑time, remote‑based position located in the United States. The role requires a willingness to travel within the U.S. with occasional travel to Europe. Employment will be through Nordberg Medical (US) Inc. Candidates must be legally authorized to work in the United States; visa sponsorship is not available.
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The Regulatory Affairs Specialist US is responsible for preparing, reviewing, and maintaining regulatory submissions and documentation required for U.S. FDA approvals of high‑risk and Class III implantable medical devices, including degradable and bioabsorbable implants. The role focuses on ensuring compliance with FDA regulations and supporting product lifecycle management from development to post‑market activities, collaborating closely with global Regulatory Affairs colleagues and cross‑functional teams.
Key Responsibilities
Prepare, review, and submit U.S. regulatory documentation, including Investigational Device Exemptions (IDE), Premarket Approval Applications (PMA), PMA Supplements, and 510(k) submissions.
Evaluate and confirm completeness and accuracy of technical and clinical documentation to support U.S. registrations.
Collaborate with global RA colleagues to align submission strategies and documentation.
Support discussions with CROs, external consultants, and FDA representatives, leveraging internal and external networks.
Review labeling, IFUs, and promotional materials for compliance with U.S. regulations.
Ensure regulatory compliance with FDA 21 CFR 807, 812, 814 and applicable guidance for PMA and 510(k) submissions.
Participate in audits and FDA inspections as a Regulatory Affairs subject matter expert.
Monitor changes in U.S. regulatory requirements and assess potential impact on products and documentation.
Maintain accurate regulatory records and tracking systems in compliance with ISO 13485 and internal quality system procedures.
Skills and Requirements Education:
Bachelor’s degree in Regulatory Affairs, Biology, Biomedical Engineering, Life Sciences, or related field.
Experience:
About 3–5 years of regulatory affairs experience in the medical device industry, specifically working with degradable implants. Preferred experience in aesthetics injectables or orthopedics. Must have prepared, reviewed, and submitted regulatory documentation and responded to FDA inquiries, used regulatory information management systems or submission tools, and worked with CROs or external partners for regulatory submissions.
Knowledge:
Strong understanding of U.S. FDA regulatory pathways, including PMA or 510(k) processes. Familiarity with ISO 13485, ISO 14971, and FDA Quality System Regulations (QSR).
Personality:
Adaptable and growth‑minded, detail‑oriented and structured, collaborative communicator, independent and proactive, capable of managing work with minimal supervision, including in a remote setting.
Other Information:
This is a full‑time, remote‑based position located in the United States. The role requires a willingness to travel within the U.S. with occasional travel to Europe. Employment will be through Nordberg Medical (US) Inc. Candidates must be legally authorized to work in the United States; visa sponsorship is not available.
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