Regulatory Affairs Specialist AMEA

About the job

We are looking for an experienced Regulatory Affairs Specialist to join our growing team, to assist CMR Senior Regulatory Affairs Specialist (AMEA) in all tasks relating to registrations for new or modified product. We are advertising this role to be based in Mumbai but we could be flexible on location in AMEA.

About CMR Surgical

CMR is an exciting and evolving company to be joining right now. Our commitment to our goal of building a world-class medical devices company is underpinned by the ground-breaking innovation of our next generation of surgical robots and a diverse team of talented and supportive individuals.

Were breaking new ground which makes working here exciting, it provides autonomy, opportunity and makes the things you do visible. Come and join us and see what youre capable of.

Responsibilities

• Reporting to the Regulatory Manager to ensure all the pre-market regulatory activities are performed and up-to-date, specific to the AMEA region under the supervision of the Senior Regulatory Affairs Specialist (AMEA).
• Supporting commercial and regional teams to provide support and guidance on regulatory matters under the supervision of the Senior Regulatory Affairs Specialist (AMEA)
• Collating all aspects of documentation required for application/submission for market authorisation under the supervision of the Senior Regulatory Affairs Specialist (AMEA).
• Support license/registration maintenance and renewals under the supervision of the Senior Regulatory Affairs Specialist (AMEA)
• Monitor, assess and deliver requirements for new and evolving regulations in the region
• Were a rapidly developing company and roles can change and evolve. Youll be willing to turn your hand to anything within the regulatory team remit that supports the team with delivering its objectives.

About You

Naturally youll have a thorough sound working knowledge of regulatory compliance in Asia, Middle East and Africa and a track record of successfully supporting regulatory approvals in these markets.

Wed also look for you to have:

• Previous experience in the medical device industry is essential for this role
• Experience in all aspects of documentation required for application/submission for market authorisation.
• Experience and knowledge of license/registration maintenance and renewals.
• Experience of working with regional regulatory authorities
• Experience of monitoring, assessing and delivering requirements for new and evolving regulations
• Demonstrated ability to engage/partner with commercial teams
• The ability to build strong working relationships with colleagues throughout the organisation and to communicate effectively
• A demonstrable hands-on approach to regulatory affairs, not being afraid to get involved with real issues.
• A perceptive and methodical approach with an ability to communicate effectively
• A desire to improve and develop existing processes by introducing efficiencies as our business grows

Please use the below link for job application and quicker response.

https://lifelancer.com/jobs/view/c1d682db860b330d5b4791acfc830c00