Regulatory Affairs Manager

Cynet Systems • Indianapolis, IN

2d

About The Position

The Regulatory Affairs Manager will be responsible for ensuring products obtain regulatory approvals in defined markets, coordinating and compiling documents for submissions, and maintaining obtained regulatory approvals and licenses throughout the product lifecycle. This role involves developing and managing global regulatory submissions and registration plans, partnering with stakeholders to provide solutions, and developing external relationships that influence product direction. The manager will also contribute to audit preparation, lead the organization in adapting to the evolving regulatory environment, and create innovative regulatory strategies to accelerate worldwide approvals. Additionally, the role requires independent initiation of activities, management of cross-departmental interactions, troubleshooting issues, and mentoring junior regulatory employees. A key aspect is managing regulatory data and promoting data stewardship, while understanding the connection between business functions, systems, processes, and data management.

Requirements

• 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.
• 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.

Nice To Haves

• Knowledge of international regulations and quality standards implementation is considered an advantage.

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior