
Senior Quality Assurance and Regulatory Affairs Leader
1 week ago
Quality Assurance and Regulatory Affairs Executive.
Job DescriptionThe position of Quality Assurance and Regulatory Affairs Executive is critical to ensuring compliance with regulatory requirements in the Medical Device Industry. The successful candidate will be responsible for leading a team in implementing quality systems, regulatory frameworks, and industry standards.
Key Responsibilities- Ensure compliance with regulatory requirements through effective risk management, clinical evaluation, and post-market surveillance (PMS).
- Coordinate with regulatory authorities, such as local FDA and CDSCO, to obtain necessary permissions and approvals.
- Manage regulatory submissions and ensure timely approvals to maintain market access.
- Identify and implement Corrective and Preventive Actions (CAPA) to maintain compliance and drive continuous improvement.
- Support audits, inspections, and ensure readiness for regulatory authority reviews.
The ideal candidate will possess excellent communication, documentation, and coordination skills, with hands-on experience in regulatory submissions, PMS, and risk management.
Required Skills and QualificationsThe successful candidate will have:
- Proven experience in Quality Assurance and Regulatory Affairs.
- Strong understanding of ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements.
- Excellent communication and documentation skills.
- Ability to coordinate with regulatory authorities and manage regulatory submissions.
- Hands-on experience in regulatory submissions, PMS, and risk management.
If you are a motivated and experienced professional looking for a challenging role, please apply today
-
Senior Regulatory Affairs Professional
1 week ago
Aurangabad, Maharashtra, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 20,00,000Legal Manager Role OverviewThe Legal Manager is a key professional position responsible for leading our legal efforts in Gurugram. This role involves strategic leadership and management of various legal tasks, ensuring compliance with regulatory affairs and drafting high-quality legal documents.
-
Regulatory Affairs Specialist
10 hours ago
Aurangabad, Maharashtra, India beBeeRegulatory Full time ₹ 8,00,000 - ₹ 12,00,000Regulatory Affairs SpecialistThe Regulatory Affairs Specialist plays a pivotal role in ensuring compliance with international guidelines and country-specific regulations.Key Responsibilities:Prepare, review, and maintain regulatory documents to guarantee adherence.Coordinate with internal teams and external stakeholders to support product registrations and...
-
Lead Regulatory Affairs Manager
13 hours ago
Aurangabad, Maharashtra, India beBeeRegulatoryAffairs Full time ₹ 12,00,000 - ₹ 25,00,000Lead Regulatory Affairs ManagerWe are seeking a highly skilled and motivated Lead Regulatory Affairs Manager to lead and manage activities in the Food Regulatory Affairs department. This role involves driving policy initiatives, liaising with government departments, engaging with industry stakeholders, generating revenue, and organizing impactful...
-
Medical Affairs Leader
4 days ago
Aurangabad, Maharashtra, India beBeeMedicalAffairs Full time ₹ 1,94,40,000 - ₹ 2,51,20,000Medical Affairs LeaderAs a medical affairs leader, you will play a crucial role in driving the company's medical strategy by providing robust medico-marketing support and facilitating collaboration between the medical and marketing teams.Main Responsibilities:Support Product Positioning: Provide medical references and data to inform product positioning and...
-
Global Regulatory Affairs Specialist
2 days ago
Aurangabad, Maharashtra, India beBeeRegulatory Full time ₹ 1,10,47,000 - ₹ 1,53,63,000Our company is seeking a skilled Regulatory Affairs Specialist to support the development and implementation of global regulatory strategies. Job Description:We are looking for a highly detail-oriented individual with excellent analytical skills to prepare variation documents, evaluate post-approval changes in compliance with global regulatory requirements,...
-
Regulatory Compliance Manager
2 weeks ago
Aurangabad, Maharashtra, India beBeeRegulatory Full time ₹ 20,00,000 - ₹ 30,00,000Senior Regulatory Affairs SpecialistThis role requires a Senior Regulatory Affairs Specialist to lead and manage CMC regulatory activities, including USFDA submissions, Annual Reports, and process validation documents.Responsibilities include leading CMC regulatory activities for USFDA submissions, overseeing compilation and submission of Annual Reports,...
-
Quality Assurance Leader
3 days ago
Aurangabad, Maharashtra, India beBeeQuality Full time ₹ 7,20,000Job Title: Quality Assurance LeaderThe successful candidate will be responsible for ensuring the highest quality of products in the Weld Shop and Paint Shop environments.Oversee the implementation of effective quality control processes to meet product specifications and industry standards.Lead a team of quality professionals to ensure efficient and effective...
-
Senior Construction Quality Assurance Manager
10 hours ago
Aurangabad, Maharashtra, India beBeeQuality Full time ₹ 1,50,00,000 - ₹ 2,00,00,000Senior Construction Quality Assurance ManagerA seasoned Senior Construction Quality Assurance Manager is responsible for overseeing quality assurance and control processes for real estate development projects.They lead a team to monitor and improve construction quality, safety, and customer satisfaction.Key Responsibilities:Developing and implementing QA/QC...
-
Regulatory Compliance Specialist
2 weeks ago
Aurangabad, Maharashtra, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 25,00,000Job SummaryWe are seeking a seasoned Regulatory Compliance Specialist to lead our team in managing complex regulatory affairs for US FDA submissions, including ANDA preparation, review, and filing.About the RoleThe ideal candidate will have hands-on experience in Regulatory Affairs – CMC with US FDA filings, especially ANDAs. They will oversee the...
-
Regulatory Compliance Specialist
1 week ago
Aurangabad, Maharashtra, India beBeeCompliance Full time ₹ 11,52,800 - ₹ 23,15,600Regulatory Affairs Expert SoughtWe are looking for 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, ensuring compliance with applicable regulations (FDA, EMA, CDSCO, MHRA,...