
Regulatory Associate- Medical Device
18 hours ago
**Job Summary**
As a Regulatory Associate in the Medical Device Industry, you will be responsible for ensuring that the company's medical devices comply with all regulatory requirements.You will work closely with cross-functional teams to ensure that products meet regulatory standards and will be responsible for preparing, submitting and maintaining regulatory documentation. You will also be responsible for monitoring and communicating changes in regulations and standards to ensure compliance.
**Responsibilities**
- You will be responsible for ensuring compliance with all applicable regulations including Drug License, FDA, ISO, and other national and international regulations.
- You will be responsible for preparing and submitting regulatory documentation for new and existing medical devices, including MDR: 2017 submissions, 510(k)submissions, technical files, and other regulatory documents.
- You will assist in the development of regulatory strategies to support the company's product development goals.
- You will communicate with regulatory agencies as necessary, and will keep cross-functional teams informed of regulatory requirements and changes.
- You will monitor changes in regulations and standards, and will work with cross-functional teams to ensure compliance with new requirements.
- You will assist in preparing for and participating in regulatory compliance audits.
- You will assist in maintaining the company's quality system, including documentation control and management.
- You will be responsible for adverse event reporting as required by regulatory agencies.
**Qualification**:Bachelor’s degree in a scientific or technical discipline (biomedical
engineering, other engineering decipline)
**Additional Qualification**: Biomedical engineer
**Experience **:Minimum 2 years
**Job Location**: Technopark,Thiruvananthapuram
**Job Types**: Full-time, Regular / Permanent
**Salary**: ₹25,000.00 - ₹45,000.00 per month
**Benefits**:
- Provident Fund
Schedule:
- Day shift
Ability to commute/relocate:
- Thiruvananthapuram, Kerala: Reliably commute or planning to relocate before starting work (required)
Application Question(s):
- What is your current monthly salary?
- What is your monthly salary expectation?
- What is your notice period?(Indays)
Work Location: In person
-
Regulatory Associate- Medical Device
4 days ago
Thiruvananthapuram, India Genrobotic Innovations Full timeAs a Regulatory Associate in the Medical Device Industry, you will be responsible for ensuring that the company's medical devices comply with all regulatory requirements. You will work closely with cross-functional teams to ensure that products meet regulatory standards and will be responsible for preparing, submitting, and maintaining regulatory...
-
Senior Medical Device Professional
6 days ago
Thiruvananthapuram, Kerala, India beBeeRegulatory Full time ₹ 1,00,00,000 - ₹ 2,50,00,000Job Title: Senior Medical Device ProfessionalAbout the RoleThis role requires a seasoned professional with a minimum of 10 years of experience in the medical device industry, preferably in healthcare products or related activities.The ideal candidate will have a solid understanding of ISO 13485, MDD 93/42/EEC, Indian Medical Device Regulations, and their...
-
Medical Device Compliance Specialist
4 days ago
Thiruvananthapuram, Kerala, India beBeeQuality Full time ₹ 15,00,000 - ₹ 22,50,000Executive QA/RA Job Description:This is a leadership role responsible for ensuring compliance with regulatory requirements and maintaining high-quality standards in the Medical Device Industry.Key Responsibilities:Ensure compliance with ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements.Coordinate with local authorities to obtain necessary permissions and...
-
Medical Device Compliance Specialist
5 days ago
Thiruvananthapuram, Kerala, India beBeeRegulatoryAffairs Full time ₹ 50,00,000 - ₹ 80,00,000Regulatory Affairs ProfessionalJob Title: Regulatory Affairs ProfessionalLocation: Remote Job Overview:We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities,...
-
Medical Device Innovator
4 days ago
Thiruvananthapuram, Kerala, India beBeeHardware Full time ₹ 15,00,000 - ₹ 25,00,000Hardware Design EngineerOur organization is dedicated to innovation in medical device development. As a Hardware Design Engineer, you will play a crucial role in revolutionizing healthcare through cutting-edge technology.Key Responsibilities:Design multi-layer PCBs for medical devices, ensuring optimal performance, reliability, and manufacturability.Create...
-
Electromechanical Medical Device Technician
4 days ago
Thiruvananthapuram, Kerala, India beBeeBiomedical Full time ₹ 8,00,000 - ₹ 12,00,000Biomedical Equipment Specialist plays a crucial role in ensuring the optimal performance and safety of medical devices used for patient care.Job Overview:Inspect and calibrate medical equipment to guarantee accuracy and functionality.Maintain precise records of maintenance and repairs performed, including troubleshooting activities.Key...
-
Medical Device Software Engineer
4 days ago
Thiruvananthapuram, Kerala, India beBeeEmbedded Full time ₹ 20,00,000 - ₹ 25,00,000Revolutionize healthcare with innovative medical device design, development, and pilot manufacturing. Our team collaborates with experts across medical, engineering, business, and research domains to bring cutting-edge solutions that enhance healthcare and improve lives.We are dedicated to driving innovation in the medical technology sector through strategic...
-
Medical Officer
1 day ago
Thiruvananthapuram, Kerala, India royal medical systems fze Full time ₹ 3,50,000 - ₹ 5,00,000 per yearJob Title:Resident Medical Officer (RMO) – TrivandrumLocation:Royal Ortho Care by Royal Medical Centre, KesavadasapuramAbout Us:Royal Medical Centre is a leading non-surgical therapeutic and wellness centre that integrates evidence-based modern medical technology with conservative treatments. We offer advanced, non-surgical solutions in spine, joint, and...
-
Thiruvananthapuram, Kerala, India beBeeManufacturing Full time US$ 30 - US$ 38Job OverviewOur organization is dedicated to pioneering breakthroughs in healthcare through collaborative innovation.Key Responsibilities:Designing and programming a robotic system for manufacturing ultrasound probesEssential Qualifications:Enrolled in a BS or MS degree program, majoring in electrical or computer engineeringMechanical aptitude desired, with...
-
Thiruvananthapuram, Kerala, India beBeeProcurement Full time ₹ 10,00,000 - ₹ 25,00,000Job Title: Senior AssociateJoin us in a rewarding opportunity as a Senior Associate to spearhead end-to-end medical equipment procurement. Your expertise will be pivotal in ensuring timely and cost-effective acquisition, negotiating with suppliers, managing vendor relationships, and upholding regulatory standards.Responsibilities:Promote best practices in...