Regulatory Affairs Manager

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:

Department

Location:

Employment Type:

Salary :

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.

Interested candidates can drop updated resumes