Manager Clinical Affairs
Location: Pune, India
Employment Type: Full-Time
Experience Required: 15–17 Years
Department: Clinical Affairs / Medical Office
Industry: Medical Devices (MedTech)
Position Overview
We are seeking an experienced Manager Clinical Affairs to lead clinical evaluation and evidence-generation activities supporting medical device development, regulatory submissions, and post-market surveillance programs. The successful candidate will provide strategic leadership in clinical affairs, oversee a team of medical writers, and ensure compliance with global regulatory requirements, particularly the European Medical Device Regulation (EU MDR 2017/745).
This role requires deep expertise in clinical evaluation documentation, regulatory compliance, clinical research methodologies, and cross-functional collaboration within a MedTech environment.
Key Responsibilities
Clinical Evaluation & Regulatory Documentation
Lead and mentor a team of Medical Writers responsible for developing high-quality clinical evaluation documents, including:
Clinical Evaluation Plans (CEP)
Clinical Evaluation Reports (CER)
State of the Art (SOTA) Reports
Post-Market Clinical Follow-up (PMCF) Plans and Reports
Ensure all documentation complies with EU MDR (Regulation (EU) 2017/745), applicable standards, regulatory guidance, and internal quality procedures.
Support preparation of clinical sections for global regulatory submissions.
Clinical Strategy & Evidence Generation
Develop and execute clinical evidence generation strategies supporting product development and lifecycle management.
Collaborate with cross-functional teams including Regulatory Affairs, Marketing, Clinical Science, Quality, Risk Management, Medical Safety, and Post-Market Surveillance.
Provide strategic input for New Product Introduction (NPI) and post-market clinical initiatives.
Design and optimize clinical study protocols to support regulatory and business objectives.
Clinical Data Review & Scientific Communication
Analyze clinical study data and clinical trial outcomes to ensure scientific validity and regulatory compliance.
Interpret and synthesize clinical evidence for regulatory, scientific, and commercial purposes.
Support claim substantiation activities and development of scientific communication materials.
Prepare and review:
Scientific abstracts
White papers
Clinical study reports
Peer-reviewed publications
Scientific presentations
Regulatory & External Stakeholder Engagement
Support interactions with regulatory authorities, including Notified Bodies and FDA.
Present clinical evidence and regulatory strategies during audits, reviews, and inspections.
Build and maintain relationships with Key Opinion Leaders (KOLs), investigators, and external clinical partners.
Facilitate execution of clinical studies and ensure generation of high-quality clinical evidence.
Leadership & Cross-Functional Collaboration
Lead, coach, and develop clinical affairs and medical writing teams.
Foster collaboration across departments to drive project success and innovation.
Manage project timelines, deliverables, and stakeholder expectations.
Present clinical findings and strategic recommendations to senior leadership and cross-functional teams.
Required Qualifications
Education
Master's Degree in Life Sciences, Clinical Research, Healthcare, Biomedical Sciences, Pharmacy, or a related discipline.
Experience
15–17 years of experience in Clinical Affairs, Clinical Research, Medical Writing, Regulatory Affairs, or related healthcare/MedTech fields.
Proven experience authoring and reviewing:
Clinical Evaluation Plans (CEP)
Clinical Evaluation Reports (CER)
State of the Art Reports
PMCF Plans and Reports
Strong working knowledge of EU MDR (Regulation (EU) 2017/745) is mandatory.
Experience supporting regulatory submissions and clinical evidence generation activities.
Preferred Qualifications
Education
MD, PhD, or equivalent advanced scientific qualification.
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