Careers

Job Overview:-

We are looking for a Marketing and Business Development Executive to support lead generation and sales coordination.

𝐊𝐞𝐲 𝐑𝐞𝐬𝐩𝐨𝐧𝐬𝐢𝐛𝐢𝐥𝐢𝐭𝐢𝐞𝐬:

• Identify new business areas and potential client contacts
• Generate, qualify, and follow up on sales leads
• Coordinate with the sales team to support lead conversion and closure

𝐄𝐥𝐢𝐠𝐢𝐛𝐢𝐥𝐢𝐭𝐲:

• B Pharma, BBA, or MBA
• Good English communication and computer skills

𝐓𝐞𝐧𝐮𝐫𝐞: Minimum 1 year

Interested candidates can apply or message directly.

👉 hr@operonstrategist.com

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: Pune
• 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: 

Job Description

We are looking for a Cyber Security Engineer(Junior-Level) to join our team at Operon Strategist, contributing to software, data, or IT system development and support. 

Key Responsibilities:

• • Develop, test, or maintain software applications, databases, or analytical tools
  • Analyze data, generate insights, and ensure system accuracy
  • Troubleshoot issues and support daily IT operations
  • Collaborate with teams to deliver high-quality, scalable solutions
  • Follow documentation, security, and testing standards

Job Requirements:

The minimum qualification for this role is Graduate and 2 – 4 years of experience. Hands-on knowledge of Python, CSIM, Firewall, Cryptography, Penetration Test, Blockchain, Backend, Testing / QA (Manual / Automation), Git / GitHub and modern tools is essential. Strong analytical, problem-solving, and communication skills required.
Skills Required:

• • Security Incident Detection and Response
  • Network Security and Firewall Management
  • Application and System Vulnerability Assessment
  • Cryptography and Public Key Infrastructure (PKI)
  • Security Information and Event Management (SIEM)
  • Penetration Testing and Ethical Hacking
  • Cloud Security and Virtualization
  • Identity and Access Management (IAM)
  • Secure Coding Practices
  • Compliance and Security Frameworks (e.g., NIST, ISO, GDPR)

Preferred Certifications (Nice to Have)

• • CompTIA Security+
  • CompTIA Network+
  • CEH (Entry Level)
  • Any relevant cyber security coursework or labs

If Interested Send CV to Mail: hr@operonstrategist.com

Job Types: Full-time, Permanent

Ability to commute/relocate:

• • Pimpri-Chinchwad, Maharashtra: Reliably commute or planning to relocate before starting work (Preferred)
  • Work Location: In person