Mona Radkani
Rancho Santa Margarita,CA
Summary
Diligent Regulatory Affairs Managers with 10 years of supporting compliance management experience. Works well with consulting cross-functional teams on minimizing regulatory risk. Goes above and beyond to manage priorities and problem-solve with quick turn-around expectation.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Regulatory Affairs Manager
Sientra Inc.
04.2023 - Current
- Provide strategic regulatory input for lifecycle management of products
- Manage regulatory submissions and ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards
- Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
- Maintain up-to-date expertise and provide specific guidance on global regulatory issues including legislation, guidelines and procedures
- Interface with regulatory agencies as necessary to facilitate product registrations and ensure regulatory compliance
- Maintain regulatory documentation for marketed products
- Review labeling for regulatory compliance and propose updates as necessary. Direct preparation of clear and concise product descriptions and other labeling components, such as principles of operation, safety warnings and precautions
- Identify resource needs and develop personnel resources to facilitate more efficient preparation of regulatory submissions, and maintenance of regulatory compliance
- Monitor evolving regulations, guidelines and standards, provide interpretative analyses of complex regulatory information and educate stakeholders as necessary
- Provide input and support for post-clinical activities and market launch of products
- Supervisory responsibilities including interviewing, hiring and training employees and planning, assigning and directing work
Sr. Regulatory Affairs Specialist
Sientra Inc.
02.2022 - 04.2023
- Support cross-functional new product development projects and lead compilation of all materials required for submissions to FDA and International Health Authorities
- Assess regulatory intelligence to assist in development of local and global regulatory strategies
- Provide support for changes to existing products, including conducting regulatory assessment of changes, and making subsequent regulatory filings
- Ensure Regulatory compliance to maintain market approvals
- Collaborate with local International RA partners to obtain product approval/clearance
- Develop and maintain regulatory affairs department procedures, SOPs, and process improvements
- Participate in Regulatory audits and support maintenance of cGMP compliant Quality Management System to ensure adherence to FDA 21 CFR 820, cGMP, and ISO 13485 regulatory requirements.
Sr. International Regulatory Affairs Specialist
Medtronic
08.2019 - 02.2022
- Participate on project teams, providing regulatory strategy, timelines, and deliverables
- Work with local International RA partners to support to obtain product approval/clearance
- Develop International regulatory strategies and timelines for product submissions, identifying needs for bench, animal and clinical testing
- Review Change Orders and assess regulatory impact of product changes on International regulatory strategy and submissions per standard procedures
- Review labeling and assess compliance against relevant regulations and product requirements
- Develop and maintain regulatory affairs department procedures and process improvements
- Comply with applicable international regulatory laws/standards and Code of Conduct
- Keeps current on global directives, harmonized standards and procedures and communicates changes that may affect cross functional areas
- Provide mentorship, training, and support to other members of department
- Assist in keeping company informed of regulatory requirements in International markets.
International Regulatory Affairs Specialist
KavoKerr
08.2018 - 07.2019
- Interact directly with International partners and distributors and develop/maintain working relationships (Middle East, Europe, Latin America, and other regions as required)
- Prepare and compile draft regulatory submissions, including preparation and maintenance of registration and renewal dossiers, Certificates to Foreign Government (CFG), Free Sale Certificates (FSC) and coordinated legalization activities
- Submit EU notifications for new and existing products in European countries
- Track product registration status and manage timelines of device registrations for existing and new registrations
- Work with Regional Sales Managers and Marketing to develop regulatory strategies for new product introduction
- Provide continuing support to International partners as product support specialist
- Participate in company's Kaizen events to improve processes.
International Regulatory Affairs Specialist
Applied Medical Resources
04.2016 - 08.2018
- Interact directly with International partners and develop/maintain working relationships (Middle East, Europe, and other regions as required)
- Prepare and compile draft regulatory submissions, including preparation and maintenance of Certificates to Foreign Government (CFG), Free Sale Certificates (FSC) and coordinated legalization activities
- Track product registration status and manage timelines of device registrations for existing and new registrations
- Work with Regional Sales Managers and Marketing to develop regulatory strategies for new product introduction
- Provide continuing support to International partners as product support specialist
- Perform change management of products and manufacturing processes which could affect regulatory listings and business operations of global partners
- Participate in project team meetings and design control process as International Regulatory Representative
- Participate in development and implementation of company-wide Product Configuration Management (PCM) process to streamline business operations and ensure regulatory compliance
- Provide continuing regulatory education and dissemination of regulatory information to team and other departments
- Develop policies, procedures (including SOP development and team work instructions) and processes to ensure high level of quality and team efficiency
- Act as team-lead within International Regulatory Affairs department
- Coordinate hiring and training of new team members, including introduction and development of team training plan
- Train new team members on products.
International Regulatory Affairs Analyst
Applied Medical Resources
06.2015 - 04.2016
- Interact directly with International global partners and develop/maintain working relationships
- Track product registration status and manage timelines of device registrations for existing and new registrations
- Provide continuing support to International partners as product support specialist
- Perform change management of products and manufacturing processes which could affect regulatory listings and business operations of global partners
- Assist in developing policies, procedures (including SOP development and team work instructions) and processes to ensure high level of quality and team efficiency.
Education
Master in Exercise Physiology (Physical Education) -
Tehran University
Tehran, Iran06.2006
Bachelors in Physical Education -
Azad University
Tehran, Iran06.2003
Skills
- Attention to detail with excellent organizational skills
- Excellent oral and written communication and presentation skills
- Fast learner with great problem-solving skills
- Outstanding analytical and critical thinking skills
- Goal-oriented team leader and team player
- Highly proficient in Microsoft Word, PowerPoint, Excel, Outlook, and Visio
- Ability to handle multiple tasks with high ethical standards
- Product Lifecycle Management
- Regulatory Strategy
- Regulatory Submissions
- Medical Device Regulations
- International Regulations
Certification
- Six Sigma Green Belt
- UCI Regulatory Affairs and Compliance courses
Working Knowledge Of Medical Device Regulations
- Central EU (Bosnia, Belarus, Serbia, Macedonia, Montenegro, Ukraine, etc)
- Middle East (Saudi Arabia, Egypt, Israel, etc)
- APAC (Japan, Thailand, Taiwan, South Korea, and Singapore)
- India Subcontinent (India, Bangladesh, Sri Lanka)
- Latin America (Argentina, Brazil, Ecuador, Venezuela, Peru, Colombia, Mexico, El Salvador, and Costa Rica)
Timeline
Regulatory Affairs Manager
Sientra Inc.
04.2023 - Current
Sr. Regulatory Affairs Specialist
Sientra Inc.
02.2022 - 04.2023
Sr. International Regulatory Affairs Specialist
Medtronic
08.2019 - 02.2022
International Regulatory Affairs Specialist
KavoKerr
08.2018 - 07.2019
International Regulatory Affairs Specialist
Applied Medical Resources
04.2016 - 08.2018
International Regulatory Affairs Analyst
Applied Medical Resources
06.2015 - 04.2016
Master in Exercise Physiology (Physical Education) -
Tehran University
Bachelors in Physical Education -
Azad University
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