Rolle und Aufgabenbereich

• Write, analyze, and edit technical documents to support country specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents, including investigational device submissions in USA, Canada, Europe and India. 
• Work with other departments and communicate the submission requirements when documents are needed for regulatory submission. 
•  Maintain regulatory files. 
• Maintain and update regulatory authorizations, such as IDEs, 510(k)s, Canadian medical device licenses, and CE dossiers for EU, NRTL certifications etc. 
• Maintain Compliance with respect to Combination products and 21CFR Part 820
• Assure that appropriate maintenance of registrations occurs including renewals, device listings, site registrations, supplements for changes and annual reports. 
• Support approval in other regions as required. 
•  Assist in preparing response to regulatory authorities questions within assigned timelines.
•  Stay abreast of regulatory procedures and changes in regulatory climate. 
•  Assess device related incidents/complaints for medical device reporting requirements.
•  Compile and submit reportable events to relevant regulatory authorities in timely manner. 
• Handle recalls and field actions, if required. 
•  Review and create product labels and review promotional material for compliance with applicable regulations and technical standards. 
•  Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance. 
•  Assist in preparing clinical trial site ethics review board applications for investigational device trials. Prepare interim or final reports for trial site ethics boards as required 
• Other duties as assigned.

Key Attributes

• Self & Team Management
• Minimum of 2 years regulatory or equivalent experience within a device or pharmaceutical company, CRO, or similar organization 
• Scientific knowledge, must be able to digest complex data while keeping the big picture through good analytical skills 
•  Excellent written and Verbal communication skills with the ability to listen, articulate and advocate 
•  Proactive, high performance, result oriented and manage projects with ethical integrity
•  Technical system skills (e.g. MS office applications, databases, efficient online research) 
• Manage multiple projects and deadlines 
• Ability to identify compliance risks and escalate when necessary 

• Demonstrate both creative and critical thinking skill

  ISO 27K-

• Maintaining awareness and adherence about applicable information security policies and procedures
• Maintaining compliance with contractual requirements
• Ensuring information, they use or information under their custody is adequately protected as per ARaymond information security expectations.
• Reporting any noted suspicious behavior, vulnerability, and incidents to authority

Ausbildung und Erfahrung

Graduation/ Post Graduation in with Specialization in Pharma/ Engineering along with 15- 20 Years of experience