Search by job, company or skills

M

Head- Regulatory Affairs

Michael Page
Bengaluru, India
10-15 Years
new job description bg glownew job description bg glownew job description bg svg
  • Posted a month ago
  • Be among the first 10 applicants
Early Applicant

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.

More Info

Job Type:
Permanent Job
Function:
Healthtech
Employment Type:
Full time

About Company

Michael Page

Michael Page has five decades of expertise in professional services recruitment. We were established in London in 1976, and over this period we've grown organically to become one of the best-known and most respected consultancies, with an office network spanning six continents.
While size has its advantages, it doesn't define us - the nature of our organic growth means that each new office is integrated into the region that it serves. It also means that as an employer looking to hire, or as a candidate aiming to grow your career you have the best of both worlds&#x3B; a team that understands the market and geography you operate in, plus the resources and expertise of an international network at your disposal.

Job ID: 126786691

Jobs by Skill - IT
Jobs by Skill - Non IT
International Jobs
Last Updated: 15-03-2026 06:44:57 PM
Homejobs in Bengaluru / BangaloreHead- Regulatory Affairs