Regulatory Affairs Manager
$48 - $53 per hourCynet Systems
Job Overview:
Pay Range: $48.00hr - $53.00hr
Requirement/Must Have:
Pay Range: $48.00hr - $53.00hr
Requirement/Must Have:
- 3-5 years of experience with PhD degree, 5-7 with Masters degree and 6-8 years with Bachelor degree in the field of IVDs, Medical devices, Pharma, or Biopharmaceutical with significant experiences in Regulatory Affairs or equivalent.
- Knowledge of XX, US, China, and other international regulations.
- Demonstrated ability to adequately interpret and implement quality standards.
- Demonstrated ability to manage high complexity work and global projects.
- Specialist knowledge in regulatory affairs.
- Experience in solving complex, critical health authority issues.
- Understanding of external environmental changes and precedents to navigate complex situations.
- Demonstrated experience and knowledge of Daily Management and Continuous Improvement best practices.
- Ensure products obtain regulatory approvals in defined markets in close cooperation with other functions.
- Coordinate and compile documents and deliverables for submissions in a timely manner to support planned product registration timelines.
- Maintain obtained regulatory approvals and licenses throughout the life cycle of the product by applying successful regulatory change controls.
- Maintain efficiency and success of regulatory activities and strategies through clear agreements with other functions, stakeholders, and external partners.
- Communicate and implement regulatory requirements and strategic aspects within the organization.
- Oversee the development of submission and product registration dossiers for complex products and programs.
- Develop and manage parts of comprehensive global regulatory submissions and registration plans.
- Partner with stakeholders to understand and provide best solutions.
- Develop external relationships that influence the current and future direction for products.
- Contribute to audit preparation and participate in audit discussions.
- Lead the organization to adapt to the evolving regulatory environment and requirements.
- Create unique and innovative regulatory strategies to avoid regulatory obstacles and accelerate worldwide approvals.
- Initiate activities independently and manage interactions across departments.
- Troubleshoot issues as they arise and implement cost-effective solutions to ensure daily work is completed without jeopardizing compliance.
- Identify problems before they occur and drive mitigation strategies.
- Mentor junior regulatory employees and share knowledge across the organization.
- Manage regulatory data and promote data stewardship within regulatory affairs teams.
- Contribute to projects with an understanding of how business functions, systems, processes, and data management are connected.
- Knowledge of international regulations and quality standards implementation is considered an advantage.
- Regulatory Affairs.
- Submission Compilation.
- Stakeholder Management.
- Strategic Planning.
- Change Control.
- Audit Preparation.
- Decision Making.
- Problem Solving.
- Agile Mindset.
- Data Stewardship.
- Strong verbal and written communication skills.
- Excellent communication and presentation skills.
- Ability to communicate effectively with stakeholders.
- Bachelor's, Master's, or PhD degree in a relevant field (IVDs, Medical Devices, Pharma, Biopharmaceutical).
Vacancy posted 3 days ago
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