Head- Regulatory Affairs

2 days ago

Bengaluru India Michael Page Full time

Job Description

- Drive regulatory strategy with global impact at a leading healthtech innovator
- Leadership role with strong visibility and growth potential

Job Description

1. Regulatory Strategy Development- Define and drive the regulatory vision and strategy for CRM products, aligning with company's business goals.
2. Leadership and Team Management- Build and lead a high-performing regulatory team, fostering a culture of excellence, innovation, and accountability.
3. Regulatory Submissions and Approvals- Oversee the preparation, submission, and maintenance of regulatory dossiers.
4. Compliance Oversight- Ensure that the equipments meet the required regulatory standards as set by CDSCO.
5. Cross-functional Collaboration- Partner with Govt affairs, Quality, Business Areas, Marketing and Legal team to integrate regulatory requirements.

The Successful Applicant

Education:

- Bachelor's or Master's degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or related fields. Advanced degrees (e.g., MBA, Ph.D.) are an advantage. .

Experience:

- Minimum 10-15 years of regulatory experience (preferably in IVD), with at least 5 years in a leadership role.
- In-depth understanding of India's Medical Devices Rules, 2017, CDSCO guidelines, and applicable standards (e.g., ISO 13485, ISO 14971).
- Familiarity with global regulations like FDA (21 CFR), EU MDR/IVDR, and other regional requirements for international market access.
- Proven track record of managing regulatory strategies for medical device company.
- Exceptional leadership, communication, and negotiation skills.
- Strategic thinker with a proactive approach to problem-solving.
- Ability to navigate complex regulatory landscapes while maintaining agility

What's on Offer

-

Leadership opportunity to head regulatory affairs for imports, driving compliance and approvals for advanced life sciences technologies.
-

Strategic exposure to regulatory authorities and global stakeholders, influencing market entry and product availability.
-

Platform to shape and strengthen the organization's regulatory framework while working with cutting-edge healthcare innovations.

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