Regulatory Affairs Specialist Resume
Headline : Detail-oriented Regulatory Affairs Specialist with 7 years of experience in ensuring compliance with regulatory standards, managing submissions, and facilitating product approvals in the healthcare sector.
Skills : Regulatory Compliance, Data Analysis, Clinical Trials, Regulatory Documentation
Description :
- Managed regulatory submissions for new products, ensuring compliance with FDA and international regulations.
- Developed and maintained regulatory documentation, including product labels and technical files.
- Collaborated with cross-functional teams to prepare and submit product annual reports to regulatory agencies.
- Conducted risk assessments and gap analyses to identify compliance issues and implement corrective actions.
- Led user acceptance testing for regulatory software systems, ensuring alignment with compliance requirements.
- Trained staff on regulatory processes and documentation standards, improving overall compliance awareness.
- Monitored changes in regulations and provided updates to the team to ensure ongoing compliance.
Experience
5-7 Years
Level
Executive
Education
MSRA
Regulatory Affairs Specialist/Executive Resume
Objective : Detail-oriented Regulatory Affairs Specialist with over 5 years of experience in medical device compliance, submissions, and product lifecycle management. Proven track record in ensuring regulatory adherence and successful product registrations.
Skills : Regulatory Submissions, Regulatory Compliance, Risk Management, Quality Assurance, Clinical Evaluation
Description :
- Collaborated with cross-functional teams to execute premarket and post-market regulatory activities, ensuring compliance throughout the product lifecycle.
- Managed adverse event reporting, including data collection, analysis, and submission of medical device reports.
- Oversaw domestic and international product registrations, ensuring timely renewals and compliance with regulatory standards.
- Led the UDI implementation process, achieving compliance for all Class I, II, and III devices ahead of deadlines.
- Assisted in defining safety and regulatory requirements for new products, ensuring alignment with industry standards.
- Performed gap analyses on regulatory documents, identifying areas for improvement and compliance enhancement.
- Participated in interdisciplinary teams for new device development, providing regulatory insights and feedback on design changes.
Experience
2-5 Years
Level
Executive
Education
MSRA
Regulatory Affairs Specialist II Resume
Headline : Detail-oriented Regulatory Affairs Specialist with 7 years of experience in managing FDA submissions, ensuring compliance, and developing regulatory strategies for medical devices and pharmaceuticals.
Skills : Regulatory Compliance, Regulatory Submissions, Risk Management, Quality Assurance, Labeling Compliance
Description :
- Managed cross-functional teams to support FDA submissions, including PMA and clinical updates.
- Authored regulatory strategies and secured 30-day approval for packaging changes in medical devices.
- Obtained regulatory approval for new product features, enhancing device performance and safety.
- Reviewed and updated product labeling to ensure compliance with global regulations.
- Identified and resolved compliance issues, leading to improved document accuracy and efficiency.
- Implemented labeling strategies to meet international barcode standards for EU compliance.
- Maintained regulatory compliance with FDA and international standards, supporting pre and post-market activities.
Experience
5-7 Years
Level
Executive
Education
MSRA
Regulatory Affairs Specialist III Resume
Summary : Dedicated Regulatory Affairs Specialist with over 10 years of experience in ensuring compliance with regulatory standards, managing submissions, and guiding clinical research projects to successful outcomes.
Skills : Clinical trial oversight, Regulatory submissions, Quality assurance, Risk assessment, Document management
Description :
- Provided regulatory guidance for clinical research projects, ensuring compliance with FDA and EMA regulations.
- Reviewed and approved clinical trial protocols, informed consent forms, and regulatory documents for accuracy and compliance.
- Conducted training sessions for project teams on regulatory requirements and best practices.
- Maintained up-to-date knowledge of regulatory changes and communicated impacts to stakeholders.
- Collaborated with cross-functional teams to develop regulatory strategies for product submissions.
- Managed the preparation and submission of IND and CTA applications, ensuring timely approvals.
- Served as a liaison with regulatory agencies, facilitating communication and addressing inquiries.
Experience
10+ Years
Level
Management
Education
MSRA
Lead Regulatory Affairs Specialist Resume
Headline : Detail-oriented Regulatory Affairs Specialist with 7 years of experience ensuring compliance with FDA regulations, managing submissions, and supporting product approvals in the pharmaceutical industry.
Skills : Regulatory Compliance, Document Management, Regulatory Submissions, Quality Assurance, Risk Assessment
Description :
- Supported regulatory activities to ensure compliance with FDA and TPD regulations for pharmaceutical products.
- Managed the creation and submission of regulatory documents, ensuring accuracy and timeliness.
- Responded to inquiries regarding product documentation and regulatory requirements.
- Collaborated with cross-functional teams to develop regulatory strategies for new and existing products.
- Reviewed and approved documents for regulatory submissions, ensuring compliance with industry standards.
- Maintained comprehensive regulatory files to support audits and inspections.
- Provided ongoing regulatory support for marketed products, addressing compliance issues as they arise.
Experience
5-7 Years
Level
Executive
Education
MSRA
Jr. Regulatory Affairs Specialist Resume
Objective : Detail-oriented Regulatory Affairs Specialist with 5 years of experience in medical device compliance and submissions. Proven track record in managing regulatory processes and ensuring adherence to FDA and international standards.
Skills : Regulatory Compliance, Regulatory Submissions, Risk Management, Quality Assurance
Description :
- Drafted and submitted regulatory documents for clinical trials, ensuring compliance with FDA regulations.
- Secured IRB approvals for clinical research protocols, facilitating timely project initiation.
- Maintained comprehensive clinical trial master files for audits by FDA and sponsors.
- Reviewed and approved study-related materials, ensuring adherence to regulatory standards.
- Communicated trial changes and protocol deviations to the review board effectively.
- Translated complex clinical protocols into clear patient consent documents.
- Coordinated cross-departmental reviews of consent forms for accuracy and compliance.
Experience
2-5 Years
Level
Junior
Education
MSRA
Regulatory Affairs Specialist/Analyst Resume
Objective : Detail-oriented Regulatory Affairs Specialist with 5 years of experience in managing submissions and compliance for FDA and international health authorities. Proven track record in ensuring regulatory adherence and optimizing processes.
Skills : Regulatory Communication, Regulatory Compliance, Submission Management, Quality Assurance, Risk Assessment
Description :
- Developed and maintained a comprehensive regulatory database for R&D documentation.
- Conducted internal audits, ensuring compliance with quality and regulatory standards.
- Monitored and disseminated updates on international regulatory guidelines.
- Interpreted and communicated regulatory changes to align corporate policies.
- Reviewed marketing materials for compliance with regulatory standards.
- Supported trade show preparations, focusing on regulatory compliance for product presentations.
- Maintained up-to-date knowledge of evolving regulations and industry standards.
Experience
2-5 Years
Level
Junior
Education
MSRA
Regulatory Affairs Specialist/Representative Resume
Summary : Detail-oriented Regulatory Affairs Specialist with 10 years of experience in global product registration, compliance, and regulatory strategy. Proven track record in managing submissions and ensuring adherence to international regulations.
Skills : Regulatory Compliance, Quality Assurance, Risk Management, Clinical Trials, Labeling Compliance
Description :
- Prepare and submit comprehensive international product registration documentation for diverse medical devices.
- Revise Summary of Technical Documentation (STED) to meet specific country requirements.
- Develop and maintain system procedures for updating registration documentation for globally marketed products.
- Initiate and manage spreadsheets for product identification, including FDA, GMDN, and HSA codes for global registration.
- Track registration status for each country through distributor and representative agents for all product lines.
- Participate in external quality system audits by FDA, FDB, and other regulatory agencies, ensuring compliance.
- Prepare and update US and international product listings, registrations, certificates, and licenses.
Experience
7-10 Years
Level
Management
Education
MS-RA
Regulatory Affairs Specialist/Co-ordinator Resume
Summary : Results-driven Regulatory Affairs Specialist with over 10 years of experience in managing regulatory submissions and compliance for medical devices. Proven track record in ensuring adherence to global regulations and facilitating product approvals.
Skills : Regulatory Submissions, Regulatory Compliance, Clinical Trials, Quality Assurance, Risk Management
Description :
- Provide comprehensive regulatory support for Class II and III medical devices, ensuring compliance with global standards.
- Coordinate and prepare regulatory submission packages, including 510(k) and IDE applications.
- Compile and manage documentation for pre-market and post-market regulatory submissions, license renewals, and registrations.
- Conduct regulatory assessments for product changes, ensuring compliance throughout the design process.
- Develop tracking systems to monitor clinical trial applications, recommending strategies for expedited approvals.
- Review and approve labeling and advertising materials to meet domestic and international regulatory requirements.
- Ensure design control processes are followed by reviewing Design History Files and Engineering Change Requests.
Experience
10+ Years
Level
Senior
Education
MSRA
Associate Regulatory Affairs Specialist Resume
Headline : Detail-oriented Regulatory Affairs Specialist with 7 years of experience in ensuring compliance with global regulations, managing product registrations, and providing strategic guidance on regulatory matters.
Skills : Regulatory Compliance, Regulatory Submissions, Risk Assessment, Quality Assurance
Description :
- Interpreted and reported on regulatory agency requirements to ensure compliance across all product lines.
- Managed global product registrations, ensuring timely submissions to regulatory agencies.
- Completed cosmetic notifications for new products and amendments to existing formulations.
- Ensured compliance with country-specific registration and listing requirements prior to product marketing.
- Analyzed and improved existing SOPs and record-keeping systems, enhancing operational efficiency.
- Served as an audit escort during regulatory inspections, facilitating communication between departments.
- Provided expert regulatory advice to management, ensuring marketing materials met compliance standards.
Experience
5-7 Years
Level
Executive
Education
MSRA
Asst. Regulatory Affairs Specialist Resume
Summary : Detail-oriented Regulatory Affairs Specialist with 10 years of experience in global regulatory submissions, compliance, and product lifecycle management. Proven track record in navigating complex regulatory environments to ensure product approval and market access.
Skills : Regulatory Compliance, Regulatory Strategy, Regulatory Submissions, Risk Assessment, Labeling Compliance
Description :
- Managed regulatory submissions for multiple products across US, EU, and Asian markets, ensuring compliance with local regulations.
- Collaborated with cross-functional teams to develop and implement regulatory strategies for new product launches.
- Created and maintained comprehensive documentation for regulatory submissions, including technical files and product labeling.
- Conducted training sessions for staff on regulatory requirements and best practices, enhancing team competency.
- Monitored changes in regulations and provided updates to stakeholders to ensure ongoing compliance.
- Led internal audits to assess compliance with regulatory standards, identifying areas for improvement.
- Coordinated with external regulatory agencies to facilitate inspections and address compliance issues.
Experience
10+ Years
Level
Senior
Education
MSRA
Regulatory Affairs Specialist Resume
Summary : Detail-oriented Regulatory Affairs Specialist with over 10 years of experience in managing regulatory submissions, compliance, and strategic planning for pharmaceutical products. Proven track record in FDA interactions and successful product approvals.
Skills : Regulatory Compliance, FDA Regulations, Clinical Trials, Risk Management, Quality Assurance
Description :
- Acted as the primary regulatory resource, ensuring compliance with all applicable regulations.
- Conducted thorough evaluations of proposed facility changes to assess regulatory impact.
- Facilitated marketing authorization filings by preparing comprehensive drug application sections.
- Authored position papers for facility modifications, ensuring clarity and compliance.
- Participated in change control processes, providing regulatory insights on proposed changes.
- Managed applications for various licenses and permits to maintain operational compliance.
- Developed and implemented a controlled substance program focused on regulatory adherence.
Experience
10+ Years
Level
Senior
Education
MSRA
