Job Description

Job discription: Manager-Medical Device

We are looking for a young, dynamic professional for the position of Manager-Medical Devices, the position will be responsible for:

Managing regulatory submissions to ensure timely filing as per the requirement of national and international regulatory including FDA 510(k), CDSCO, CE Marking, and others.

Performing Gap assessment.

Responding to regulatory queries.

Conducting internal quality audits as per ISO standards.

Providing support for ISO Certification, including ISO 13485, ISO11135, ISO 11137, ISO 11737, ISO 14971 and other relevant standards.

Verification of design and development documentation and validation.

Collaborate with quality team to ensure effective implementation of quality management systems.

You should have:

Strong knowledge of global medical device regulations and standards

Experience with preparation, regulatory submissions and certification management, including FDA 510(k), CDSCO Medical Device Registration, Import, and Manufacturing Licenses in India, CE Marking under the EU Medical Device Regulation (MDR), Saudi Food and Drug Authority (SFDA) requirements for Saudi Arabia, UK CA Marking for the United Kingdom.

Knowledge of 21 CFR 820 is desirable

Excellent project management and organizational skills

Ability to collaborate with cross-functional teams

Strong analytical and problem-solving skills

Able to articulate thoughts clearly, concisely, and professionally in English.

Well versed in Microsoft Word, Excel, PowerPoint.

Knowledge of 21 CFR Part 11 is an added advantage.

Qualification:

Bachelor's or Master's degree in pharmacy/Engineering, Regulatory Affairs, Life Sciences, or a related field.
Experience: 2 - 8 years

Location: Pimpri Chinchwad, Pune.

Job Type: Full-time

Pay: ?30,000.00 - ?70,000.00 per month

Benefits:

Health insurance Provident Fund
Schedule:

Day shift
Work Location: In person