Director of Regulatory Affairs — Interim, Medical Devices

The mandate

The company needs to prepare a principal high-risk device dossier that reconciles clinical, usability and manufacturing evidence for regulatory submission. The Director of Regulatory Affairs role is vacant, and functional leaders require alignment on the resubmission standard to support launch economics.

The interim should join within four weeks for eleven months through resubmission and substantive regulator response. The assignment ends when an internal deputy, already identified, takes over after authorisation or a documented final decision.

Handover requires a technically complete resubmission accepted for review, closure of all major questions within agreed response times, market authorisation in the priority jurisdiction, and a traceable core dossier reusable for the next two markets.

The director may define submission strategy, reject inadequate evidence and approve external expertise below ₹70 lakh. New clinical studies, indication changes and response commitments affecting launch above ₹2 crore need product-committee consent; Regulatory cannot alter test results or direct Quality release.

Pricing, distributor selection and next-generation product development are outside the assignment. The team should avoid adding commercial wishes that are not supported by the existing intended use and evidence.

Why this seat is open

The refusal exposed fragmented authorship and weak senior review rather than one missing document. The previous director chose to leave rather than lead a disciplined rebuild. A time-limited specialist is needed to set the evidentiary bar, carry regulator dialogue and prepare the deputy to inherit a coherent system.

What you will own

• Reconstruct the refusal rationale into an evidence-gap matrix with accountable scientific and engineering owners.
• Decide the core regulatory strategy, claims perimeter and sequencing across the three target jurisdictions.
• Reject contradictory clinical, risk, usability or manufacturing evidence before dossier assembly.
• Chair regulator meetings and issue contemporaneous commitments, owners and response dates after each interaction.
• Approve a controlled core dossier with jurisdiction-specific deltas and end-to-end traceability.
• Run independent red-team reviews against the refusal points before formal resubmission.
• Qualify the internal deputy through authored responses, mock meetings and final dossier defence.

Candidate qualifications

• Eighteen-plus years in medical-device regulatory affairs with high-risk hardware, software or combination-product submissions.
• Personal recovery of a refused, withdrawn or materially deficient submission through subsequent market authorisation.
• Deep familiarity with clinical evaluation, usability engineering, risk management, design transfer and manufacturing evidence.
• Direct regulator-meeting experience in India and at least one major international regulated market.
• Ability to constrain intended-use or claim ambition when evidence cannot support the commercial preference.
• Proven coaching of regulatory successors through live questions rather than document review alone.