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Bonetech Medisys Hiring Senior Regulatory Affairs Executive
Bonetech Medisys Pvt. Ltd.
Senior Regulatory Affairs Executive Vacancy | Bonetech Medisys
Apply for Senior Regulatory Affairs Executive role at Bonetech Medisys Pvt. Ltd. Full-time position with global regulatory compliance responsibilities.
Bonetech Medisys Pvt. Ltd., a trusted name in the medical devices industry, is inviting applications for the role of Senior Regulatory Affairs Executive. This is a full-time opportunity for professionals seeking to build a career in global regulatory compliance, ensuring products meet international standards and safety requirements. If you have experience with EU MDR, FDA 510(k), ISO 14971, and IEC 62366-1, this role provides an excellent platform to showcase your expertise.
Company Overview
Bonetech Medisys Pvt. Ltd. is a leading healthcare and medical devices company committed to innovation, quality, and global compliance. With a strong focus on developing advanced orthopedic and surgical solutions, Bonetech Medisys works with international regulatory frameworks to bring safe and effective products to market. The company emphasizes quality assurance, patient safety, and continuous improvement, making it a reliable name in the industry.
Job Role & Responsibilities
As a Senior Regulatory Affairs Executive, you will play a critical role in ensuring that Bonetech’s products comply with global regulatory requirements. Your responsibilities will include:
- Preparing and updating regulatory submissions in line with EU MDR and FDA 510(k) requirements.
- Developing and maintaining risk management documentation as per ISO 14971 and usability engineering under IEC 62366-1.
- Reviewing and approving product labeling, IFUs (Instructions for Use), surgical technique guides, and promotional materials for regulatory compliance.
- Developing and updating SOPs to align with evolving regulatory requirements.
- Leading and compiling documentation for product registrations, license renewals, and market approvals.
- Monitoring global regulatory changes and ensuring timely compliance updates.
- Acting as a regulatory representative in new product development (NPD) teams, advising on global compliance strategies.
- Liaising with Notified Bodies, FDA, distributors, and suppliers on regulatory matters.
- Supporting and leading external audits/inspections, coordinating with auditors.
- Providing regulatory training to cross-functional teams and maintaining awareness of quality system requirements.
- Monitoring vigilance databases for adverse events and recall trends.
Eligibility / Qualifications
- Education: B. Pharm, M. Pharm, M.Sc (Life Sciences), Biomedical Engineering, or equivalent degree.
- Experience: 3–7 years in Regulatory Affairs (Medical Devices/Pharma preferred).
- Certifications: Knowledge of EU MDR, FDA 510(k), ISO 13485, ISO 14971, IEC 62366-1.
- Skills Required: Strong understanding of global regulatory processes, excellent communication skills, and ability to manage audits and submissions.
Location & Salary
- Job Type: Full-time
- Location: India (Company HQ: Bonetech Medisys Pvt. Ltd.)
- Salary: Competitive, based on qualifications and experience.
Application Process
Interested candidates can apply by sending their updated resume to:
- Email: hr@bonetechmedisys.com
- Phone: +91 95128 57704
- Website: www.bonetechmedisys.com
FAQs
1. Who can apply for the Senior Regulatory Affairs Executive role?
Candidates with a background in pharmacy, life sciences, or biomedical engineering, along with regulatory experience in EU MDR and FDA compliance, are eligible.
2. Is prior experience mandatory?
Yes, candidates should have 3–7 years of experience in regulatory affairs, preferably in medical devices or pharma.
3. What certifications are required?
Hands-on knowledge of EU MDR, FDA 510(k), ISO 13485, ISO 14971, IEC 62366-1 is required.
4. What is the salary range for this role?
Salary is competitive and based on candidate’s experience and expertise.
5. What is the scope of this role?
This role involves global regulatory compliance, audits, risk management, labeling, and acting as a regulatory point of contact with authorities.
Apply before 23rd August 2025 to secure your place in Bonetech’s regulatory team!
Summary Table
| Company | Bonetech Medisys Pvt. Ltd. |
|---|---|
| Vacancies | Senior Regulatory Affairs Executive |
| Required Education | B. Pharm, M. Pharm, M.Sc, Biomedical Engineering |
| Experience | 3–7 years in Regulatory Affairs |
To apply for this job email your details to hr@bonetechmedisys.com