JOIN DHARMA CONSULTING

We Build Teams of Independent Problem-Solvers

Dharma Consulting is not for everyone. We are a lean remote team operating in a high-accountability environment. We hire people who identify problems independently, create their own action plans, and deliver without being chased.

HOW WE WORK

Our Culture

Objective-Driven

You receive the goal, the context, and the tools. The path, the plan, and the execution are yours to own.

Self-Managed

You own your tasks, your timelines, and your outcomes. We review, not micromanage.

Fully Remote

Monday to Saturday. 5:30 PM – 2:30 AM IST (EST overlap). India-based. Fully remote.

Written-First

All client communication is documented and logged. Daily timesheet notes are required. Clarity is a professional standard here.

CURRENT OPENINGS

Open Positions 2 Positions Available

Regulatory Affairs Consultant

Apply Now →
Remote Full-Time Contract Monday–Saturday 5:30 PM–2:30 AM IST 2–5 Years Experience

Dharma Consulting provides regulatory and quality consulting services to the medical device and pharmaceutical industry. We work with US-based clients, supporting their global regulatory and quality operations across US, EU, and Switzerland markets.

We are hiring a Regulatory Affairs Consultant to independently manage regulatory data, compliance tracking, and gap analysis for one of our US-based medical device clients.

What You Will Own
Own the accuracy and completeness of product registration data across multiple global regulatory databases — identify what's outdated, prioritize, execute, and report progress without being asked
Manage data submissions and updates across EU and Swiss regulatory platforms in compliance with EU MDR
Review and interpret medical device product labels — understand key attributes and how they relate to regulatory submissions
Perform gap analysis between client procedures and eIFU position paper requirements — identify gaps, engage SMEs, and drive closure independently
Drive regulatory gap analyses to closure — track open items, coordinate with subject matter experts, and escalate when timelines slip
Maintain organized, audit-ready regulatory trackers and documentation in Excel and Word
Document detailed timesheet notes every working day — tasks performed, systems accessed, and progress made
What You Need
2–5 years of experience in Regulatory Affairs or Medical Device industry
Familiarity with regulatory data attributes — labeling, IFUs, UDI, GUDID, and EUDAMED
Exceptional English reading and writing skills — drafting communications and trackers for senior stakeholders
Strong attention to detail — one wrong data entry has serious compliance consequences
Strong proficiency in Microsoft Excel and Word
Understanding of medical device regulatory frameworks — EU MDR is a strong plus
Familiarity with Agile PLM or similar EDMS/QMS platforms
Familiarity with RIMS or similar regulatory information management systems
Ability to take a high-level objective and independently break it into tasks, timelines, and deliverables
Self-discipline to work remotely without constant oversight
Nice to Have
Degree in Biomedical Engineering, Life Sciences, Pharmacy, or related field
Familiarity with global regulatory databases and submission platforms
Knowledge of MDCG guidelines or eIFU requirements
Apply Now →

Quality Consultant — MES Implementation / Process Standardization

Apply Now →
Remote Full-Time Contract Monday–Saturday 5:30 PM–2:30 AM IST 2–5 Years Experience

Dharma Consulting is hiring a Quality Consultant to support a large-scale MES implementation project — transitioning from paper-based batch records to electronic batch records (eBR) across five global manufacturing sites.

Your role is process standardization — learning how each site currently operates, identifying gaps, and developing a single global standard all five sites can follow.

This is a fast-paced environment. You will use AI tools (such as Microsoft Copilot) to rapidly learn project details, review meeting summaries, and understand complex processes.

What You Will Own
Study manufacturing process flowcharts and understand how MES interacts with QMS, training, ERP, tool management, and labeling systems
Develop and implement standardization actions — understand current site practices, propose unified global standards, and drive them to approval
Own key quality processes including sampling plans (ISO 2859), in-process controls, operator qualifications, and eBR requirements
Support change control processes — track impact assessments, document required actions, and ensure all changes are properly evaluated and closed before system build
Review meeting summaries, identify follow-up tasks, and consolidate information from multiple cross-functional meetings into structured documents
Communicate with stakeholders across five sites in different time zones — drive alignment through clear, professional written communication
Track progress of all actions, flag risks early, and deliver without being chased
What You Need
2–5 years in Quality Assurance, Quality Systems, or Quality Engineering in medical device or pharmaceutical industry
Knowledge of ISO 13485
Understanding of change control processes and impact analysis
Exceptional English reading and writing skills — non-negotiable
Strong attention to detail and ability to read and interpret process flowcharts
Proficiency with Microsoft Excel, Word, PowerPoint, Project, OneNote, and JIRA
Ability to leverage AI tools to accelerate learning, research, and documentation
Self-driven — you take a high-level objective and independently break it down into tasks, timelines, and deliverables
Nice to Have
MES experience or familiarity with electronic batch recording (eBR)
CQE or CQA certification
Familiarity with ISO 2859, QMS platforms, or ERP systems (SAP)
Compensation: Competitive and based on demonstrated ability to independently manage responsibilities. Candidates who demonstrate proactive ownership and consistent delivery will qualify for higher compensation.
Apply Now →
THE PROCESS

How to Apply

1

Submit

Send your CV and a short paragraph (5–8 sentences) via the application form. Describe a time you identified a problem, built your own action plan, and executed it without being told to. Generic responses will not be considered.

2

Screening

Short written screening round. No video interview for first round. We assess how you think and communicate in writing.

3

Discussion

Final conversation with the team lead. Scoped engagement offer if there's a mutual fit.

Strict Confidentiality Is Mandatory

All candidates will be required to sign an NDA and Communication Policy before starting. No client information is shared externally. All client communication goes through approved written channels only. Any breach is grounds for immediate termination.