Are you passionate about ensuring medical devices meet global regulatory standards? Bonetech Medisys, a leader in innovative medical solutions, is hiring a Senior Regulatory Affairs Executive in Ahmedabad, Hathijan. This role offers a unique opportunity to shape the future of healthcare by driving compliance and supporting groundbreaking medical device innovations. If you’re a detail-oriented professional with expertise in EU MDR, FDA 510(k), and ISO standards, join a team where your skills make a global impact.
Key Responsibilities
As a Senior Regulatory Affairs Executive, you’ll play a pivotal role in ensuring compliance and fostering innovation. Your responsibilities include:
- Preparing and updating EU MDR and FDA 510(k) submissions to meet stringent regulatory requirements.
- Leading risk management and usability processes in line with ISO 14971 and IEC 62366-1.
- Reviewing product labeling, Instructions for Use (IFUs), and promotional materials for compliance.
- Guiding New Product Development (NPD) teams on global regulatory strategies.
- Liaising with Notified Bodies, regulatory authorities, and global partners.
- Monitoring global regulatory changes and managing compliance audits.
- Training cross-functional teams on medical device regulatory standards.
Qualifications
We’re looking for a driven professional with the following qualifications:
- Bachelor’s degree in science, engineering, or a medical/technical field.
- 5+ years of experience in medical device regulatory affairs.
- In-depth knowledge of EU MDR, FDA regulations, and ISO 13485.
- Strong organizational skills, attention to detail, and a collaborative mindset.
- Proven experience handling audits and global regulatory submissions.
Benefits
Joining Bonetech Medisys means being part of a company that pushes the boundaries of healthcare innovation. Benefits include:
- Competitive salary range: INR 8,00,000 – 12,00,000 per annum.
- Opportunity to work on cutting-edge medical device projects.
- Collaborative and inclusive work environment.
- Professional growth through training and global exposure.
- Chance to make a meaningful impact on global healthcare.
How to Apply
Ready to lead with purpose? Send your CV and a cover letter to hr@bonetechmedisys.com by September 21, 2025. Ensure your application highlights your regulatory affairs experience and passion for medical device compliance. Early applications are encouraged, as we review candidates on a rolling basis.
- +91 95128 57704
- hr@bonetechmedisys.com
- www.bonetechmedisys.com
FAQs
Q: What is the application deadline for the Senior Regulatory Affairs Executive role?
A: Applications are accepted until September 21, 2025. Apply early to secure your spot!
Q: Does Bonetech Medisys offer remote work for this position?
A: This role is based in Ahmedabad, Hathijan, and requires on-site presence due to collaboration with cross-functional teams and regulatory bodies.
