Senior Executive Regulatory Affairs Job in Poly Medicure Limited

Job Description

The ideal candidate will be responsible for driving the company's key performance indicators by delivering an exceptional in Regulatory affairs with knowledge of well established technologies & legacy products.

Responsibilities:

• Sound knowledge and understanding of EU procedures MDD, MDR, MDCG, CER and MEDDEV papers
• Sterilization procedures and respective validation
• Clinical Evaluation report writing/proof-reading
• Hands on Experience in and management as per EN ISO 14971
• Processing of incident reports (MIR format of EU)
• Independent creation and maintenance of technical documentation as per MDD and MDR
• Purchase and delivery specifications
• Preparation for international products approvals (registrations)
• Define and support CAPA in the common interface between second party and Polymed
• verification planning for development projects
• Supervision/adoption of test methods according to international norms
• Support to second party audit team during annual assessment certification body.
• Conversation to the client and Quality checks of models, drawings & assembles according to client standard & their checklists

Qualification & Experience:

• Bachelor of Technology in Mechanical Engineering / M.Sc. in Medical Technical Engineer, Pharmacy, Healthcare Technology
• 4 to 6 years experience in MD RA and EU MDD
• Sound experience in single use MDs, class I-III
• Strong verbal or written communication skills