Remote Pharma Job in Bengaluru Senior Associate Regulatory Affairs Jobs ClinChoice , global exposure, compliance role for experienced pharma professionals.
Company Overview
ClinChoice is a global life sciences solutions organization known for supporting pharmaceutical, medical device, and healthcare innovators across the product lifecycle. With decades of experience in regulatory affairs, clinical operations, biometrics, pharmacovigilance, and medical affairs, the company delivers structured, compliant, and data-driven solutions to meet complex global regulatory expectations. Its international delivery model enables collaboration with global clients while offering professionals in India exposure to high-impact regulatory projects. Remote Pharma Job in Bengaluru
Job Location & Employment Type
- Location: Bengaluru, Karnataka, India
- Work Mode: Remote / Work from Home
- Employment Type: Full-Time
- Job Function: Regulatory Affairs – Regulatory Operations (EU MDR)
Open Positions / Department Details
- Position: Senior Associate – Regulatory Affairs (Reg Ops EU MDR)
- Department: Regulatory Affairs – Medical Devices
- Experience Level: Mid-Senior (4 to 6 Years)
This role is designed for experienced regulatory professionals who have hands-on exposure to European Union Medical Device Regulation (EU MDR) requirements and regulatory operations activities. The position involves close coordination with global regulatory teams, cross-functional stakeholders, and client representatives. Remote Pharma Job in Bengaluru
Key Roles & Responsibilities
As a Senior Associate in Regulatory Affairs – Regulatory Operations, the selected candidate will play a critical role in ensuring EU MDR compliance for medical device documentation and submissions. Key responsibilities include: Remote Pharma Job in Bengaluru
- Collaborating closely with client-side regulatory project teams to plan, track, and execute regulatory documentation activities aligned with EU MDR (Regulation (EU) 2017/745).
- Identifying applicable regulatory requirements, harmonized standards, and Medical Device Coordination Group (MDCG) guidance relevant to technical documentation and design dossiers.
- Collecting, reviewing, and consolidating Technical File (TF) and Design Dossier (DD) documentation from internal systems such as PLM or other regulatory repositories.
- Converting, compiling, and organizing regulatory documents into structured Adobe PDF files suitable for regulatory review and submission.
- Creating accurate bookmarks, indexes, and document navigation structures within PDF files to meet regulatory submission expectations.
- Uploading finalized documentation into regulatory systems through approved change management or change order processes.
- Performing detailed quality control checks as per internal SOPs, client procedures, and predefined checklists to ensure completeness, correct pagination, and document integrity.
- Verifying that all regulatory documents are free from missing pages, blank sections, or formatting errors before submission or resubmission.
- Coordinating with internal teams and regional affiliates to obtain mandatory legal and regulatory certificates such as Certificates of Free Sale (CFS), Certificates to Foreign Government (CFG), and other supporting documents.
- Responding to regulatory queries raised by health authorities, notified bodies, or regional affiliates in a timely and professional manner.
- Proactively escalating regulatory risks, documentation gaps, or submission challenges to regulatory management and project stakeholders.
- Representing the Regulatory Affairs function in cross-functional project meetings and providing regular updates on regulatory timelines and deliverables.
- Maintaining consistent communication with regulatory leadership regarding project progress, workload, and compliance status.
- Supporting additional regulatory operations or compliance activities as assigned based on business needs.
Remote Pharma Job in Bengaluru
Eligibility Criteria
Education
- Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Biomedical Engineering, or a related scientific discipline is preferred.
Experience
- Minimum 4 to 6 years of professional experience in Regulatory Affairs with a strong focus on EU MDR regulatory operations.
- Proven experience working with medical device technical documentation, regulatory submissions, and compliance activities.
Skills Required
- Strong working knowledge of EU MDR (2017/745) requirements and regulatory expectations.
- Practical understanding of ISO 13485 quality management systems and US FDA medical device regulations.
- Experience handling regulatory documentation within PLM or similar document management systems.
- High attention to detail with strong document review and quality control capabilities.
- Proficiency in Microsoft Word, Excel, and PowerPoint for regulatory documentation and reporting.
- Excellent written and verbal communication skills in English.
- Ability to work independently in a remote environment while meeting strict regulatory timelines.
Remote Pharma Job in Bengaluru
Salary & Benefits
- Compensation: As per company norms
- Additional benefits and incentives will be aligned with organizational policies and role expectations.
Remote Pharma Job in Bengaluru
Selection Process
- Application shortlisting
- Technical and regulatory interviews
- Final HR discussion
The selection process may vary based on project requirements and client expectations.
How to Apply
Interested and eligible candidates can apply through the online application process as per the company’s official hiring procedure.
Important Dates
- Application timelines will be communicated through the official job posting.
- Early applications are encouraged due to limited openings.
Why Apply for This Pharma Job?
This opportunity is ideal for regulatory professionals seeking long-term growth in EU medical device compliance. The role offers exposure to global regulatory projects, remote work flexibility, and hands-on involvement in EU MDR submissions and maintenance activities. Candidates will gain experience working with international clients, advanced regulatory systems, and cross-functional global teams—making this position a strong career move for professionals aiming to specialize in regulatory operations.
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform. We are not directly affiliated with any pharmaceutical or medical device company. Job details are shared for informational purposes only. Candidates are advised to verify official notifications before applying. Remote Pharma Job in Bengaluru
Final Call-to-Action
If you have strong EU MDR regulatory operations experience and want to work on global medical device projects, apply now and advance your regulatory career. Remote Pharma Job in Bengaluru
