Regulatory Affairs Manager

About the Company:
We are a dynamic and innovative organization dedicated to advancing healthcare through cutting-edge technology and regulatory excellence. Our focus is on delivering safe and effective solutions in the medical and pharmaceutical industries, ensuring compliance with global standards.

About the Role:
We are seeking an experienced Regulatory Affairs Manager to join our team. This role is pivotal in leading and managing regulatory strategies to ensure compliance and successful product approvals in the medical device and pharmaceutical sectors. It requires a seasoned professional with substantial experience in regulatory affairs and people management.

Key Responsibilities:

• Develop and implement regulatory strategies for product approvals in global markets.
• Lead and manage a medium to large-sized team, providing guidance and support in regulatory submissions.
• Collaborate with cross-functional teams to ensure compliance with regulatory requirements.
• Prepare and review regulatory documents, ensuring accuracy and adherence to industry standards.
• Monitor changes in regulations and update internal processes accordingly.
• Communicate effectively with regulatory authorities and stakeholders to facilitate product approvals.

Requirements:

• Bachelor’s degree in Engineering or Science (e.g., Software Engineering, Electrical Engineering, Mechanical Engineering, Biomedical Engineering).
• Minimum of 15 years of regulatory experience in the medical or pharmaceutical industry.
• At least 5 years of experience in people leadership, managing medium to large-sized teams.
• Proficiency in Microsoft Office Suite and database trending analysis.
• Strong verbal and written communication skills.
• Ability to understand the functionality and intended use of complex medical devices.
• Proactive approach to leading technical initiatives and multitasking abilities.
• Minimal travel may be required.

Preferred Qualifications:

• Proven track record in successful regulatory submissions.
• Strong leadership experience and skills in managing teams.

Location:
Hyderabad, India