Regulatory Affairs Manager
2 hours ago
Company Description
Ace Cathtech Pvt Ltd, established in April 2024, is a cutting-edge manufacturer of premium medical devices, specializing in Nephrology Products, Cardiac Surgery Equipment, Critical Care, and Anesthesia Products. Located in Faridabad, Haryana, our state-of-the-art facility adheres to the highest manufacturing standards, including a Class 7 cleanroom environment as per CDSCO guidelines. Our team follows strict Standard Operating Procedures (SOPs) to ensure quality control and patient safety. We are committed to delivering innovative solutions that enhance patient care and well-being.
Job Title:
Regulatory Affairs Manager
Department
: Regulatory Affairs
Location:
IMT, Sector-68, Faridabad
Employment Type:
Full-Time
Salary :
50k-60k (Negotiable)
Position Summary:
The Regulatory Affairs Manager is responsible for managing and overseeing regulatory activities to ensure that the company's medical products (e.g., medical devices, diagnostics, healthcare equipment) comply with applicable global regulatory requirements. This role supports product development, registration and post-market activities by providing strategic regulatory guidance and managing submissions to regulatory authorities such as the FDA, EMA, MHRA and other global agencies.
Key Responsibilities:
- Develop and execute regulatory strategies to support new product development, international registrations, and post-market compliance.
- Prepare, review and submit regulatory filings such as 510(k), PMA, CE Mark technical files, Design Dossiers and other country-specific submissions (e.g., TGA, Health Canada).
- Ensure compliance with applicable standards and regulations (e.g., FDA 21 CFR 820, ISO 13485, MDR 2017/745, IVDR).
- Serve as the primary liaison with regulatory bodies, managing responses to inquiries, deficiency letters and audits.
- Monitor and interpret changes in global regulations that may affect the company's products and proactively communicate implications to internal teams.
- Collaborate cross-functionally with R&D, Quality Assurance, Clinical Affairs and Manufacturing to ensure regulatory requirements are integrated into product development processes.
- Support product labeling, advertising, and promotional review for regulatory compliance.
- Lead or assist in regulatory inspections and internal audits.
- Maintain regulatory documentation, submissions, and approvals in accordance with internal SOPs and external regulations.
- Mentor or supervise junior regulatory staff as needed.
Qualifications:
Education: Bachelor's degree must.
Experience:
- 5+ years of regulatory affairs experience in the medical device or diagnostics industry.
- Hands-on experience with FDA submissions (510(k), PMA), CE Marking and international regulatory requirements.
- Knowledge of quality management systems and regulatory frameworks (e.g., ISO 13485, MDSAP, EU MDR/IVDR).
Skills:
- Strong understanding of global medical device regulations.
- Exceptional organizational, analytical and problem-solving skills.
- Excellent written and verbal communication skills.
- Ability to manage multiple projects with shifting priorities.
- Detail-oriented and proactive in resolving issues and ensuring compliance.
-
Executive Export Regulatory Affairs
7 days ago
Delhi, Delhi, India Hamdard Full time ₹ 12,00,000 - ₹ 36,00,000 per yearEXECUTIVE -REGULATORY AFFAIRS Export Regulatory Affairs will be responsible for managing and coordinating regulatory submissions, product registrations, and compliance activities for international markets. This role ensures that all documentation and submissions meet the regulatory standards and timelines of target export countries, while supporting business...
-
Medical Affairs Manager
1 week ago
Delhi, Delhi, India Gadgeon Medical Systems Pvt Ltd. Full timeAbout WebcardioWebcardio is a leading provider of innovative cardiac monitoring solutions, offering Doctors and patients real-time, remote cardiac diagnostics through advanced wearable ECG technology. Our mission is to improve cardiac care delivery using AI driven insights and seamless technology.Role OverviewThe Medical Affairs Manager will lead and oversee...
-
Regulatory Affairs Assistant Manager
5 days ago
Delhi, Delhi, India abca10e5-b8f0-4661-b869-ae7e93dad3ac Full time ₹ 4,50,000 - ₹ 5,00,000 per yearJob Description:New submissions:a. Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions. b. Review documents (Development report, scale up report, specification, stability protocol, analytical validation), etc. Before initiation of Exhibit batches for adequacy.Approval : Review & prepare response to deficiency enabling...
-
Delhi, Delhi, India Maruti Suzuki Full time ₹ 12,00,000 - ₹ 36,00,000 per yearPosition:DM / MGRFunction:Corporate Affairs (CPA)Experience:~3-7 years (preferably in the auto industry)Location:Maruti Suzuki Head Office, Vasant KunjRole Overview:We are looking for a dynamic, sharp, and self-driven professional to join our growing Corporate Affairs team. The role involves translating complex automotive policy issues into clear, compelling...
-
Delhi, Delhi, India Narula Exports Full time ₹ 4,00,000 - ₹ 12,00,000 per yearPrepare and submit regulatory submissions, including product registrations, variations, renewals, and licenses to various Authorities in different countries. Apply and manage CDSCO licenses (e.g., ISO 13485, MDR 2017/745, US FDA, etc.). Required Candidate profileExcellent written and verbal communication skills with the ability to produce high quality...
-
Strategic Affairs
4 days ago
Delhi, Delhi, India Avaada Full time ₹ 4,00,000 - ₹ 12,00,000 per yearJob Description: -Relationship-building, liaison, and obtaining licences, permits, and approvals related to the company's business.The ability to coordinate with statutory organisations, such as Mantralaya, State Departments (Energy, Revenue, Home, Industry, State Nodal Agencies, SLDCs), and Local Administration (at the district level), to carry out...
-
Lead (Auto) - Group Public Affairs
2 weeks ago
Delhi, Delhi, India Mahindra & Mahindra Limited Full time ₹ 15,00,000 - ₹ 30,00,000 per yearPurpose of the role The role plays important link between business and policy makers both at Central Govt level and State Govt level. This role brings in business perspective and thus protecting business interest while Govt shapes various policies for the sector. Absence of this role will lead to missing organisation interest in the policies and will miss...
-
BIS Expert – Regulatory Compliance
6 days ago
Delhi, Delhi, India ELT Corporate Private Limited Full time ₹ 4,00,000 - ₹ 12,00,000 per yearExperience:1-2 YearsLocation:Rohini Sector-3, New DelhiCompany:ELT Corporate Private LimitedCompany DescriptionELT Corporate Private Limited is India's leading regulatory and market-access consulting company, assisting manufacturers, importers, and exporters in obtaining statutory certifications such as BIS, Legal Metrology, CDSCO, CE,USFDA,EPR, and AEO....
-
Medical Affairs Partner, Oncology
1 week ago
Delhi, Delhi, India Roche Full time ₹ 12,00,000 - ₹ 36,00,000 per yearAt Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure...
-
Compliance and Regulatory Manager
1 week ago
Delhi, Delhi, India Sysfol Enterprises Full time ₹ 12,00,000 - ₹ 36,00,000 per yearWe are looking for a seasoned Regulatory Compliance Manager. The role will focus on ensuring regulatory, legal, labelling, quality, and ESG compliance.This position involves working closely with cross-functional teams to drive regulatory strategy, manage submissions and approvals, ensure compliance with global labelling & barcoding standards, and support...