Job Description
🚀
We’re Hiring: Regulatory Affairs Specialist
📍 Location:
Valsad, Gujarat (On-Site)
🏢
Company
Brulon
Brulon is looking for a driven and detail-oriented
Regulatory Affairs Specialist
to join our growing team and support global regulatory compliance for our expanding portfolio of dental medical devices.
Key Responsibilities
- Prepare and maintain international regulatory dossiers / product registrations
- Develop complete Technical Documentation / Technical Files
- Prepare BEP, BER, CEP, CER, PMS & PMCF documentation
- Manage regulatory / notified body query responses and remediation
- Support EU MDR, MDSAP, ISO 13485, and global compliance activities
- Monitor international regulatory requirements and submission timelines
- Coordinate with cross-functional teams for regulatory readiness
Preferred Qualifications
- Bachelor’s degree in Life Sciences, Pharmacy, Bioengineering, Chemistry, or related field
- 3–7 years of Regulatory Affairs experience in medical devices / dental products
- Strong knowledge of EU MDR 2017/745, ISO 13485, MDSAP, 21 CFR 820
- Experience in Technical Documentation, Clinical Evaluation, and International Registrations
- Strong documentation, analytical, and communication skills
📩 Interested candidates can apply by sending their CV to
hr@brulon.in or message us directly on LinkedIn.
#Hiring #RegulatoryAffairs #MedicalDevices #DentalIndustry #EU_MDR #ISO13485 #MDSAP #CER #BER #TechnicalFile #PMS #PMCF #ValsadJobs #Brulon
Want AI-powered job matching?
Upload your resume and get every job scored, your resume tailored, and hiring manager emails found - automatically.
Get Started Free