Career Opportunity as a CDSCO Medical Device Specialist at JR Compliance

Unlock your potential and embark on a career journey that combines your expertise with a dynamic work environment. JR Compliance is inviting applications for the position of CDSCO Medical Device Specialist, offering a unique opportunity to contribute to the regulatory landscape in the medical device industry.

As a CDSCO Medical Device Specialist at JR Compliance, you’ll play a pivotal role in ensuring regulatory compliance within the ever-evolving medical device sector. This position offers a unique chance to navigate the complexities of regulatory frameworks, contribute to product registrations, and stay at the forefront of advancements in the industry.

Job Title: CDSCO Medical Device Specialist

Qualifications:
1. Bachelors or Master’s degree in Pharmacy, Life Sciences, or a related field.
2. Minimum 1+ years of experience in regulatory affairs within the [Cosmetics/Medical Devices] industry, with a focus on CDSCO regulations and utilizing the Sugam Portal.
3. Sound knowledge of CDSCO regulations and guidelines pertaining to [Cosmetics/Medical Devices], especially related to the Sugam Portal.
4. Familiarity with the registration process for [Cosmetics/Medical Devices] in India, including dossier preparation and submission requirements via the Sugam Portal.
5. Strong understanding of quality management systems and Good Manufacturing Practices (GMP) in the [Cosmetics/Medical Devices] industry.
6. Excellent attention to detail and ability to interpret complex regulatory information.
7. Effective communication and interpersonal skills to collaborate with internal and external stakeholders.
8. Proactive problem-solving abilities and ability to work independently with minimal supervision.
9. Ability to prioritize tasks, meet deadlines, and adapt to changing regulatory requirements.

Salary: 25k to 40k

Job Description:
We are currently seeking a skilled and motivated CDSCO Regulatory Affairs Specialist to join our team and ensure compliance with regulatory requirements for our [Cosmetics/Medical Devices] portfolio, specifically focusing on the Sugam Portal and RA Department.

Responsibilities:
1. Develop and execute regulatory strategies for [Cosmetics/Medical Devices] in accordance with CDSCO (Central Drugs Standard Control Organization) regulations and guidelines, particularly using the Sugam Portal.
2. Prepare and submit product registration applications, dossiers, and other necessary documentation through the Sugam Portal.
3. Collaborate with cross-functional teams, including R&D, Quality Assurance, and Marketing, to gather necessary information and support for regulatory submissions via the Sugam Portal.
4. Keep up-to-date with the latest regulatory developments, changes, and trends in the [Cosmetics/Medical Devices] industry, specifically related to the Sugam Portal, and communicate the impact to relevant stakeholders.
5. Review and assess labelling, packaging, and advertising materials to ensure compliance with CDSCO regulations via the Sugam Portal.
6. Coordinate and support regulatory inspections and audits conducted by regulatory authorities, utilizing the Sugam Portal as necessary.
7. Maintain accurate and up-to-date records of all regulatory documentation, submissions, and approvals facilitated through the Sugam Portal.
8. Provide regulatory guidance and support to internal teams, including training on regulatory requirements and processes related to the Sugam Portal.

Requirement:
1. Should be experience in Medical device registrations.
2. Minimum 1+ years of experience in regulatory affairs within the [Cosmetics/Medical Devices] industry, with a focus on CDSCO regulations and utilizing the Sugam Portal.

Location: Paschim Vihar, New Delhi

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