Regulatory Affairs Analyst – Medical Devices

Job Description

We are building a specialized team to support global medical device companies with regulatory documentation, MDR compliance, and lifecycle support.

As a Regulatory Affairs Analyst, you will work closely with senior experts to execute and draft regulatory documentation across the product lifecycle, supporting compliance with global standards including EU MDR 2017/745, ISO 13485, and ISO 14971.

This is a hands-on role focused on documentation, analysis, and regulatory execution.

Roles & Responsibilities

Regulatory Documentation & Compliance

  1. Prepare and draft GSPR (General Safety and Performance Requirements) checklists
  2. Assist in the creation and maintenance of Technical Documentation / Technical Files
  3. Support MDR remediation activities (MDD to MDR transition)
  4. Ensure documents are aligned with MDR Annex II & III requirements

Clinical Evaluation Support

  1. Support preparation of Clinical Evaluation Reports (CER) and Clinical Evaluation Plans (CEP)
  2. Conduct systematic literature searches using databases (e.g., PubMed, Google Scholar)
  3. Extract, analyze, and summarize clinical data
  4. Assist in state-of-the-art analysis and clinical data appraisal

Risk Management Documentation

  1. Support preparation of Risk Management Files as per ISO 14971
  2. Assist in:
  3. Contribute to Risk Management Reports (RMR)

Technical File & Submission Support

  1. Assist in compiling and structuring regulatory submission dossiers
  2. Maintain traceability matrices and document cross-references
  3. Ensure consistency across documentation sets
  4. Support labeling and IFU documentation review

Regulatory Intelligence & Research

  1. Track updates in global medical device regulations
  2. Prepare summarized regulatory intelligence reports
  3. Support standards mapping and applicability assessments

Cross-Functional Collaboration

  1. Work closely with senior regulatory experts for review and validation
  2. Coordinate with internal teams for data collection and documentation inputs
  3. Participate in internal quality checks and document reviews

Skills

1.Education

Bachelor’s or Master’s degree in:

  1. Biomedical Engineering
  2. Life Sciences
  3. Biotechnology
  4. Pharmacy or related field

2.Experience 

2–4 years of experience in:

  1. Medical device regulatory affairs
  2. Technical documentation / CER / risk management

3.Technical Skills

Strong understanding of:

  1. EU MDR 2017/745
  2. ISO 13485
  3. ISO 14971

Experience with:

  1. GSPR checklist preparation
  2. Clinical literature review & medical writing
  3. Risk management documentation
  4. Technical Skills

4.Core Competencies

  1. Strong medical writing and documentation skills
  2. Excellent analytical and research abilities
  3. High attention to detail
  4. Ability to work in a structured, process-driven environment
  5. Good communication skills (written & verbal)

5.Tools & Systems (Good to Have)

  1. PubMed / scientific databases
  2. MS Word (advanced formatting)
  3. Excel (data handling, tracking)
  4. Document management systems (e.g., PLM tools like Windchill, Agile – optional)

What You’ll Gain

  1. Exposure to global regulatory frameworks
  2. Hands-on experience with MDR documentation and submissions
  3. Opportunity to work with international MedTech clients
  4. Fast learning curve in a growing regulatory services environment

Ideal Candidate Profile

  1. Detail-oriented and process-driven
  2. Comfortable working on documentation-heavy tasks
  3. Interested in building expertise in medical device regulatory affairs
  4. Able to manage multiple deliverables within timelines

Required Qualification

  1. 2 to 4 years experience in web application development
  2. Any Graduates or Any Post Graduates
  3. Good interpersonal skills with the ability to present ideas in user-friendly language.
  4. Successful experience working in a team-oriented, collaborative environment.
  5. Proven analytical and problem-solving abilities.
  6. Excellent communication both written and verbal.
  7. Strategic thinker with strong influencing skills and the ability to build consensus.
  8. Strong action orientation; ability to make things happen.

How to Apply

  1. Share your updated resume with relevant experience in regulatory documentation, CER, or risk management.