Regulatory Manager

Lead and mentor a team of regulatory professionals, fostering a culture of excellence and continuous improvement

Provide guidance on complex regulatory issues and training on new regulations

Develop and execute global regulatory strategies to support product approvals and market access

Collaborate with cross-functional teams (R&D, Quality, Marketing etc.) to ensure alignment of regulatory requirements with business goals of the client

Manage interactions with regulatory authorities to facilitate timely approvals

Ensure compliance with relevant standards and regulations, including ISO 13485, EU MDR, FDA 21 CFR 820, QMSR, ISO 14971, IEC 62304, IEC 62366 and other applicable country wise and global requirements

Manage regulatory impact assessments for design and manufacturing changes

Oversee regulatory activities for product updates, labeling changes and post-market surveillance

Monitor and interpret evolving regulations to anticipate and manage changes

Ensure compliance of verification, validation and testing protocols with applicable standards

Bachelors or MasterDegree in Biomedical Engineering, Mechanical Engineering, Electronics Engineering or related fields. Advanced degrees are preferred.

15-20 years of regulatory experience in the medical devices industry, with a proven track record of successful submissions and approvals

Strong knowledge of global regulatory frameworks, including US FDA, EU MDR, Health Canada, TGA etc.

Strategic thinking with a deep understanding of regulatory affairs

Excellent leadership, project management and communication skills

Ability to interpret and apply complex regulatory requirements effectively

Relevant certifications such as RAC or equivalent are highly desirable