Regulatory Affairs Specialist
2 weeks ago
Role Overview:
Responsible for preparing, reviewing, and maintaining regulatory submissions and product registrations to ensure compliance with CDSCO, US FDA, and EU MDR requirements.
Key Responsibilities:
- Prepare and compile regulatory submissions (e.g., Device Master File, Technical File, 510(k), CE marking, etc.).
- Ensure compliance with ISO 13485, EU MDR 2017/745, US FDA 21 CFR Part 820, and local regulatory guidelines.
- Review labeling, IFUs, and promotional materials for compliance.
- Manage product registration, renewals, and post-market submissions.
- Monitor regulatory updates and standards relevant to medical devices.
- Support internal and external audits, providing necessary documentation.
- Collaborate with R&D, QA, and manufacturing teams for regulatory input.
Qualifications:
- B.Pharm / M.Pharm / M.Sc (Regulatory Affairs, Biotechnology, or Life Sciences).
- Minimum 6 years’ experience in Regulatory Affairs for medical devices.
- Strong knowledge of device registration process and QMS standards.
- Experience interacting with Notified Bodies / Regulatory Authorities preferred.
-
Regulatory Affairs Manager
1 week ago
Faridabad, Haryana, India Polymed Full time ₹ 4,00,000 - ₹ 12,00,000 per yearJob Title: Manager (RA)Location: FaridabadDepartment: Regulatory Affairs (RA)Job Overview:We are seeking a meticulous Documentation Officer / Manager to manage regulatory documentation and ensure compliance with ISO 13485, EU MDR, FDA, and other regulatory standards.Key Responsibilities:Prepare, maintain, and review regulatory documentation as per ISO 13485,...
-
Investor Relations Specialist
1 week ago
Faridabad, Haryana, India, Haryana Netweb Technologies India Ltd. Full timeJob SummaryThe Investor Relations Manager will be responsible for managing communication between the company, its investors, analysts, and the broader financial community. The role requires strong understanding of the Indian capital markets, SEBI regulations, stock exchange compliance, and experience working in a listed (public limited) company...
-
Senior Analyst – Management Consulting
1 week ago
Hisar, Haryana, India, Haryana Mercados Energy Markets India Full timeA. About Mercados Energy Markets India Pvt. LtdMercados Energy Markets India Pvt. Ltd. (Mercados) is a specialist consultancy firm, exclusively focused on business solutions in the energy and environment domain. Since the beginning of its operations in India in 2008, Mercados has been supporting clients across the energy sector value chain. We strive to...
-
Chief Administrative Officer
2 weeks ago
Panchkula, Haryana, India, Haryana Venus Remedies Limited Full timeRole & responsibilitiesChief Administrative Officer (CAO)Venus Remedies LimitedPurpose & Vision AlignmentThe Chief Administrative Officer serves as the administrative visionary of Venus Remedies,transforming our operational backbone from functional execution to strategic enablement. As the architect of our administrative excellence across seven critical...
-
Regulatory Affairs Specialist
7 days ago
faridabad, India vueverse. Full timeRole Overview:Responsible for preparing, reviewing, and maintaining regulatory submissions and product registrations to ensure compliance with CDSCO, US FDA, and EU MDR requirements.Key Responsibilities:Prepare and compile regulatory submissions (e.g., Device Master File, Technical File, 510(k), CE marking, etc.).Ensure compliance with ISO 13485, EU MDR...
-
Regulatory Affairs Specialist
2 weeks ago
India, Cochin / Kochi / Ernakulam Bayfield Food Ingredients Full timeJob Description About Bayfield Food Ingredients Bayfield Food Ingredients is a pioneering provider of innovative, high-quality food ingredients, specializing in natural flavors, extracts, and sustainable solutions. Our mission is to empower healthier food choices for consumers while prioritizing ethical sourcing and environmental responsibility. At Bayfield,...
-
Regulatory Affairs Specialist
2 weeks ago
faridabad, India vueverse. Full timeRole Overview:Responsible for preparing, reviewing, and maintaining regulatory submissions and product registrations to ensure compliance with CDSCO, US FDA, and EU MDR requirements.Key Responsibilities:Prepare and compile regulatory submissions (e.g., Device Master File, Technical File, 510(k), CE marking, etc.).Ensure compliance with ISO 13485, EU MDR...
-
Regulatory Affairs Specialist
1 week ago
faridabad, India vueverse. Full timeRole Overview: Responsible for preparing, reviewing, and maintaining regulatory submissions and product registrations to ensure compliance with CDSCO, US FDA, and EU MDR requirements. Key Responsibilities: Prepare and compile regulatory submissions (e.g., Device Master File, Technical File, 510(k), CE marking, etc.). Ensure compliance with ISO 13485, EU MDR...
-
Regulatory Affairs Submissions Lead
2 weeks ago
Faridabad, India vueverse. Full timeRole Overview:Responsible for preparing, reviewing, and maintaining regulatory submissions and product registrations to ensure compliance with CDSCO, US FDA, and EU MDR requirements.Key Responsibilities:Prepare and compile regulatory submissions (e.G., Device Master File, Technical File, 510(k), CE marking, etc.).Ensure compliance with ISO 13485, EU MDR...
-
Regulatory Affairs Associate
1 week ago
India Cisbio Full time**Responsibilities**: Location India - Remote, IN Job ID JR-031455 PerkinElmer is a global technology company focused on improving the health and safety of people and the environment. The Regulatory Affairs Specialist will support our Diagnostics Business that focuses on products targeted to improve human health. He/she will support regulatory submissions...
-
Regulatory Affairs Manager
4 days ago
Mumbai, India aasaannaukri Full timeJob Description Role Description This is a full-time on-site role for a Regulatory Affairs Manager based in Mumbai. The primary responsibilities include ensuring compliance with regulatory requirements, preparing and submitting regulatory documents, and maintaining the organization's quality systems. The role also involves monitoring updates to regulations...
-
Ahmedabad, Gujarat, India, Gujarat MJ Surgical Full timeWe are Hiring Regulatory Affairs Specialist For Medical Devices (OrthopedicImplants And Instruments) Role & Responsibilities:1. Documents Preparation for ISO13485, CE Certificate (As Per EU MDR), USFDA.2. Work On Technical Master File.3. Work On CERs (Clinical Evaluation Report) As Per EU MDR.4. Work on Design & Development and Risk Management Files as per...
-
Regulatory Affairs
2 days ago
Maharashtra, India, Govandi USV Full timeear Candidate,We are seeking a Senior Executive/ Assistant - Regulatory affairs Europe) to join our team, He/ she will be responsible for Dossier compilation, preparation, Life cycle management, Pre approval, Post approvals. based at Govandi Location.Markets : EuropeDosage Form : OSD/ SterileKey Responsibilities:● Collate/prepare and file dossiers in...
-
Regulatory Affairs Executive
2 weeks ago
Ahmedabad, Gujarat, India, Gujarat BKM Health Pvt Ltd Full timeRegulatory Affairs Executive :(BKM) is seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, eCTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like...