Regulatory Affairs Executive at Andheri
Regulatory Affairs Executive at Andheri
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
Job Title: Regulatory Affairs
No of Vacancy: 1
Job Location: Andheri West
Years of Experience: 1-4years
Working Days: Monday to Saturday
Job Summary:
We are seeking a motivated and detail-oriented Regulatory Affairs Executiveto join our team. The ideal candidate will be responsible for preparing and maintaining regulatory documentation to ensure compliance with domestic and international regulations across global markets including India the US and the EU. This role requires strong coordination skills and a proactive approach to support product registrations audits and technical submissions.
Key Responsibilities:
Conduct gap analysisof existing regulatory and technical documentation.
Prepare and maintain regulatory submissions including:
lDevice Master Files
lRisk Management Files
lDesign History Files
lClinical Evaluation Reports
lUsability Reports
Draft and update product labeling content such as Instructions for Use (IFUs) implant cards and declarationsto meet global compliance requirements.
Support regulatory submissionsfor India (via CDSCO/SUGAM/NSWS) US (FDA) EU (CE marking under MDR) and other applicable markets.
Coordinate with cross-functional teams including Purchase Accounts Legal Marketing and R&Dto gather documentation and resolve queries.
Assist in preparing and submitting responses for audit-related queriesand regulatory inspections.
Contribute to regulatory strategy for new product developmentsand modifications.
Stay updated with changes in regulatory requirements and industry trends through self-learning and structured training.
Educational Qualifications:
Bachelors or Masters degree in Pharmaceutical Sciences Engineering Biotechnology Microbiology or a related life science field.
Specialization in Regulatory Affairsor Quality Assurancepreferred.
Experience:
1 to 4 yearsof industry experience in a Regulatory Affairs role preferably in medical devices pharmaceuticals or life sciences.
Hands-on experience with global and domestic regulatory submissions.
Exposure to documentation systems and regulatory portals (CDSCO/SUGAM/NSWS) is essential.
Experience or knowledge of software regulationsis an added advantage.
Key Skills and Competencies:
Strong knowledge of:
Regulatory frameworksincluding ISO 13485 EU MDR and 21 CFR Part 820
Risk management design controls and post-market surveillance
Excellent documentation analytical and technical writing skills
Proficient in Microsoft Office Suiteand digital documentation platforms
Strong interpersonal skills to collaborate with internal departments and external bodies
Soft Skills:
Go-getter attitudewith the willingness to lead and take initiative
High English proficiency both verbal and written
Strong organizationaland time managementskills
Ability to work independently and as part of a cross-functional team.
Fast learner with a proactive mindset for continuous development.
Monday to Saturday working
Company Website:
Junior IC
Employment Type
Full-Time
Key Skills
Similar Jobs
Dr. Job is an online platform that connects employers with skilled job seekers, facilitating the search for job opportunities and top talent. Established in 2015. Dr. Job Pro has emerged as the world premier job portal, attracting thousands of job seekers every day from all over the world.
Follow Dr.Job
Dr Job FZ LLC. 2025 © All Rights Reserved