Regulatory Affairs Executive

Regulatory Affairs Executive — Job Description

Role purpose

Keep every product Dawell imports and sells legally registered, licensed and tender-ready.

Manage regulatory affairs and product compliance for imported detection/medical devices (CDSCO, BIS, legal metrology and import licensing).

Key responsibilities

• Handle device registration, import licences and CDSCO/BIS compliance
• Maintain regulatory dossiers, certificates and renewals
• Support tenders with compliance and statutory documents
• Liaise with authorities and OEMs on regulatory matters
• Track regulatory changes impacting the portfolio
• Track the medical-device and IVD rules (MDR 2017) for licensed products
• Maintain the regulatory document library used in tenders

System responsibilities (Odoo)

• Device registration, import licences and CDSCO/BIS/legal-metrology compliance
• Maintains regulatory dossiers, certificates and renewals; supplies tender statutory docs

Key result areas & indicative targets

Targets are indicative and are finalised in the KRA appraisal for each financial year.

Qualifications & experience

• M.Pharm / M.Sc (Life Sciences); RA certification preferred
• Experience: 3–6 years in regulatory affairs for devices / IVD

Technical skills

• Regulatory affairs
• CDSCO/BIS
• Documentation
• Liaison
• CDSCO / MDR 2017 & IVD rules
• BIS / legal metrology
• Import licensing
• Regulatory dossiers

Skill catalogue (Odoo): Service reports & documentation, Technical compliance & bid evaluation

Behavioural competencies

• Accountability & reliability
• Clear communication
• Learning agility & technical curiosity
• Attention to detail
• Customer & service orientation
• Precision
• Persistence
• Liaison skills

Certifications & compliance

• Regulatory affairs certification (preferred)
• Adherence to Dawell HR Policies v2.0 (POL/00–23), incl. POL/02 Attendance, POL/05 Travel & Expenses, POL/22 Delegation of Authority

Working conditions

Pune HQ; visits to authorities

Career path

RA Executive → RA Manager

Selection process

1. Application & CV screening (HR, within 5 working days)
2. HR screening call
3. Technical / product round
4. Manager interview (Head / MD for senior roles)
5. Offer & reference check
6. Joining & induction (Dawell eLearning + POL/00–23 policy acknowledgement)

About Dawell Lifescience

Dawell Lifescience Pvt. Ltd. (Pune) is an authorised Indian partner for forensic, narcotics, toxicology, counterfeit-detection and public-safety technologies — Thermo Fisher (TruNarc, TruScan, Gemini), Abbott SoToxa, Dräger (alcohol, drug testing, CBRN, SCBA, gas detection) and FARO 3D crime-scene systems — serving police, forensic labs, excise, health / FDA, defence, CAPF and PSU buyers through tenders, GeM and direct orders.