Alcon Hiring for Clinical Evaluation & Regulatory Medical Writing

Alcon is hiring for the position of Sr. Associate, Clinical Research (Non-MD) in Bangalore, India. The role focuses on clinical evaluation documentation, systematic literature reviews, clinical evidence assessment, and regulatory compliance for medical device products.

Candidates with experience in EU MDR 2017/745 regulations, clinical evaluation, regulatory medical writing, systematic literature reviews, or clinical research can apply.

Job Details

Position

Senior Associate – Clinical Research (Non-MD)

The selected candidate will support the development and maintenance of clinical evaluation reports, clinical evaluation plans, PMCF documentation, and systematic literature review reports for assigned medical device products.

Key Responsibilities

• Author, co-author, and update Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), PMCF Plans and Reports, and Systematic Literature Review (SLR) documentation.
• Ensure clinical evaluation deliverables comply with EU MDR 2017/745, applicable MDCG guidance, and relevant MEDDEV guidance.
• Develop and execute literature search strategies, conduct screening, extract data, appraise evidence, and prepare evidence summaries.
• Integrate clinical, post-market, risk management, PMS, PMCF, labeling, and state-of-the-art evidence into clinical evaluation documents.
• Collaborate with Regulatory Affairs, Medical Safety, Design Excellence, and Quality teams.
• Address cross-functional review comments and maintain documentation consistency.
• Manage assigned deliverables within agreed timelines and communicate project risks and dependencies.
• Support process improvements, template refinements, and knowledge-sharing initiatives.
• Maintain document version control, traceability, data integrity, and audit-ready documentation.
• Develop technical independence and manage clinical evaluation deliverables of increasing complexity.

Eligibility and Qualifications

Candidates must meet the following requirements:

• Bachelor’s Degree, Master’s Degree, PhD, or Pharm.D.
• Minimum 3 years of relevant professional experience.
• Experience in one or more of the following areas:
  • EU MDR 2017/745 medical device regulations.
  • Clinical evaluation and clinical evidence.
  • Regulatory medical writing.
  • Systematic literature reviews.
  • Clinical research or related scientific/regulatory functions.
• Experience in ophthalmic medical devices is preferred.

Required Skills and Technical Knowledge

• Working knowledge of EU MDR 2017/745 clinical evaluation requirements.
• Familiarity with MEDDEV 2.7/1 Rev. 4 and applicable MDCG guidance.
• Understanding of Post-Market Clinical Follow-up (PMCF) and Post-Market Surveillance (PMS).
• Knowledge of risk management interfaces and benefit-risk concepts.
• Ability to prepare and update CERs, CEPs, PMCF Plans/Reports, and SLR documentation.
• Understanding of research methodology, clinical study design, literature review methods, and evidence appraisal.
• Strong analytical thinking, attention to detail, and documentation skills.
• Proficiency in Microsoft Office, literature databases, reference management tools, and document management systems.
• Ability to work with cross-functional and global teams.