Careers
Job Openings
Role Overview
We are hiring an Sales Executive who can independently manage enquiries on CRM, client engagement, proposal development, and deal closure for our medical device regulatory and consulting services. The role includes defined revenue targets and performance-based incentives.
Required Qualifications & Experience
- Bachelor’s degree in Biomedical Engineering, Life Sciences, Pharmacy, Biotechnology, or Business
- 2–3 years of experience in B2B sales or business development
- Experience in medical devices, regulatory consulting, pharma, CRO, or life sciences services preferred
- Strong negotiation, communication, and presentation skills
- Ability to independently manage the full sales cycle.
What Operon Strategist Offers
- Competitive CTC with potential Incentives.
- Exposure to global medical device regulatory projects
- Clear career progression to Senior Level Executive.
- Continuous learning in regulatory affairs and compliance
- Professional, collaborative work culture
Job Types: Full-time, Permanent
Benefits:
- Health insurance
- Provident Fund
Location:
- PCMC, Maharashtra
Work Location: In person
Job Overview:-
Operon Strategist is inviting applications for the position of Regulatory Affairs Specialist to join our regulatory team. If you have experience in SIMD/SaMD regulatory submissions, Medical SDLC documentation, and global regulatory compliance, this role offers an excellent opportunity to work with a leading medical device consulting firm.
- Job Title: Regulatory Affairs Specialist – SaMD / Digital Health
- Location: Remote
- Education: Bachelor’s degree in Biomedical Engineering, IT, Computer Engineering, or a related field
- Experience: 1 to 4 years of Regulatory Affairs experience (SaMD/Digital Health preferred)
✨ Key Responsibilities:
- Preparing, compiling, and submitting regulatory documentation for FDA 510(k), CE Marking (MDR), UKCA, and other global submissions
- Ensuring SaMD development complies with IEC 62304, ISO 14971, ISO 13485, ISO 27001, and relevant cybersecurity standards
- Maintaining up-to-date knowledge of global SaMD regulations including FDA guidance, EU MDR Annex VIII, IMDRF SaMD frameworks
- Supporting design and development documentation including risk management, clinical evaluation, labeling, and technical files
- Managing regulatory communication with Notified Bodies, Competent Authorities, and other regulatory agencies
- Supporting post-market surveillance, vigilance reporting, and compliance activities
- Participating in internal and external audits and inspections
- Monitoring evolving global regulatory requirements and communicating their impact to internal teams
👉 Key Skills:
- Strong knowledge of global SaMD regulatory frameworks
- Excellent written and verbal communication skills
- Ability to interpret technical documentation and translate regulatory requirements into actionable tasks
- Strong organizational, analytical, and project management abilities
💡 Preferred:
- Experience with Agile software development
- Knowledge of AI/ML in SaMD and related regulatory considerations