Regulatory Affairs Specialist – Medical Devices

We are currently looking to hire a ' Regulatory Affairs Specialist ' to join our team. Based on your background, we believe you could be a great fit for this role!

Position : Regulatory Affairs Specialist

Location : Ahmadabad (Work From Office)

Job brief

This is an opportunity to work in a key role with a broad spectrum of responsibilities in a growing healthcare company that has expanded in various domains in the industry and to contribute to the growth of the company. The vision is to build strong medical device portfolio in the regulated markets across the world, where the regulatory function plays a crucial role in this development. The Regulatory Affairs Specialist reports to the site head in India

Roles & Responsibilities

The individual will be working on regulatory requirement of Medical devices and Distribution in various markets

 Coordinate successful submissions and approval of all medical device approval applications with various regulatory authorities worldwide

 Keep up-to-date with changes in regulatory legislation and guidelines for medical devices across various markets

 Write comprehensible, user-friendly, clear product information leaflets and labels

 Review and report overall quality status to the management team

 Use a variety of specialist computer applications

 Explain regulations, policies, or procedures for medical device fillings

 Maintain data in information systems or databases

 Evaluate applicable laws and regulations to determine impact on company activities

 Provide technical review of data or reports

 Advice the operations and business team on applicable regulatory requirements, project specific regulatory issues as assigned.

 Act as back-up for contact with Regulatory Agencies as needed.

 Draft cover letters for Regulatory Agency communication.

 Assist with timely availability of submission documents and ensure that all document components are in place on time.

 Draft and review some document content (depending on level of regulatory knowledge / expertise).

 Understand submission details and liaise with Submission Management.

 Review of submission documents to ensure compliance with regulatory requirements.

Desired Skills / Experience :

 Thorough understanding and demonstrated ability to apply regulatory guidelines / regulations to successful dossier preparation, submission and maintenance

 Strong initiation and organizational skills

 Basic analytical skill and technical / scientific competence

 Attention to details and ability to appropriately assess risks and formulate risk management strategies

 Proactive, quick learner and independent worker able to effectively multi-task in a high pressure environment and follow issues through to conclusion

Working Hours

You will be working from India in Dayshift from 1 : 00 p.m. to 10 : 00 p.m.

If you're currently exploring new opportunities, we'd love to connect and tell you more about this role.

Skills Required

"Regulatory Affairs Specialist", "Regulatory Affairs Associate", "Regulatory Affairs Manager", "Regulatory Specialist", "RA Specialist", "Regulatory Compliance", "Medical Device", "Medical Devices", "FDA-regulated products", "EU MDR", "Technical File", "Design Dossier", "Regulatory submissions", "Product registration", "Post-market surveillance"