Job Opportunity: Regulatory Affairs Executive at Orikam Healthcare in Jhajjar
This Regulatory Affairs Executive Job at Orikam Healthcare India Private Limited is a timely opportunity for aspiring professionals in the regulatory affairs field. This role is based in Jhajjar, Haryana, and is ideal for candidates with a B.Pharm degree looking to work in the medical devices sector. The position offers a competitive salary of ₹22,000 to ₹24,000 in hand, with applications currently open.
About the Company
Orikam Healthcare India Private Limited is a prominent player in the dental and medical devices industry, specializing in products such as endodontic files, intraoral sensors, and Cone Beam Computed Tomography (CBCT). The company is dedicated to ensuring compliance with industry standards and regulations, making it a key contributor to the medical devices sector in India. Orikam Healthcare operates in alignment with regulatory frameworks such as CDSCO MDR 2017 and ISO certifications, ensuring high-quality standards in all its offerings.
Job Details
- Position: Regulatory Affairs Executive
- Location: Village Yakubpur, Tehsil Badli, Jhajjar, Haryana
- Qualification: B.Pharm
- Salary: ₹22,000 – ₹24,000 in-hand
- Working Days: 6 days a week
Regulatory Affairs Role: Job Description
In this medical device regulatory affairs role, the Regulatory Affairs Executive will play a vital role in ensuring compliance with regulations governing medical devices. Responsibilities include the preparation and review of essential documents such as DMF, PMF, IFU, labels, and technical documents. The candidate will support CDSCO regulatory submissions and respond to regulatory queries while assisting with risk management, biocompatibility, clinical evaluation, and PMS documentation. Familiarity with SUGAM and NSWS portals is essential, and the candidate will coordinate with various teams to ensure adherence to CDSCO MDR 2017, ISO 13485, ISO 14971, ISO 10993, US FDA, and EU MDR.
Key Responsibilities
- Preparation and review of DMF, PMF, IFU, labels, and technical documents.
- Support CDSCO regulatory submissions and responses to regulatory queries.
- Assist with risk management, biocompatibility, clinical evaluation, and PMS documentation.
- Review product classification, intended use, labeling, and certificates.
- Hands-on experience with SUGAM and NSWS portals.
- Coordinate with QA, R&D, production, and other teams.
- Ensure compliance with CDSCO MDR 2017, ISO 13485, ISO 14971, ISO 10993, US FDA, and EU MDR.
Eligibility Criteria
Candidates with relevant experience in medical device regulatory affairs will be preferred for this position.
Required Skills
- Strong understanding of regulatory requirements for medical devices.
- Experience with document preparation and review.
- Familiarity with regulatory submissions to CDSCO.
- Knowledge of risk management and biocompatibility standards.
- Excellent communication and coordination skills.
How to Apply
- Interested candidates can share their CVs at hr1@orikam.in or contact Anupriya Gupta at+91 97738 96559 via call or WhatsApp. No official ATS or form is required for applications.
Why Join Orikam Healthcare?
Joining Orikam Healthcare means becoming part of a dedicated team that is committed to excellence in the medical devices sector. The organization fosters a collaborative environment where employees can grow professionally while contributing to the development of innovative dental and medical products. With a focus on regulatory compliance and quality assurance, Orikam Healthcare provides a platform for individuals to enhance their skills in regulatory affairs.
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In conclusion, this regulatory affairs position at Orikam Healthcare offers a promising career path for B.Pharm graduates. With a competitive salary and the chance to work in a dynamic medical devices environment, qualified candidates are encouraged to apply. This role not only provides a chance to work with regulatory affairs but also contributes to the advancement of medical technology. Interested individuals should apply at the earliest to secure their position in this exciting field.
