Syneos Health job vacancy for Sr.Regulatory Associate -Medical Device | Apply Now

India-Asia Pacific – IND-Home-Based, India

JOB SUMMARY

Provide regulatory and technical support for assigned product development & maintenance projects, including product development & maintenance documents and regulatory agency/Notified bodies (NB) submissions, implementing/managing project regulatory activities, and supporting clients and project teams.

•      Should have Minimum 2 years of experience in medical device regulatory submissions.
•       Must have Good exposure in EU medical Device regulations.
• Good understanding of ISO’s, Technical Documentation, GSPR, QMS and other regulations such as ASTM, etc.
   JOB RESPONSIBILITIES

For non-complex and complex submissions, independently fulfill the following responsibilities:

• ·       Conduct research of existing product data relative to global or regional regulatory requirements for the preparation of gap analyses, product development plans, and other regulatory submissions.
• ·       Contribute to or prepare administrative and technical components of regulatory agency submissions for pre-approval submission packages, for device registration applications, and for post-approval maintenance.  Contribute to or support the agency interactions. 
• ·       Manage and/or operationalize the delivery of day-today regulatory activities for assigned project according to agreed timelines, scope of contract, budgets, and strategies.
• ·       Participate as regulatory support on multidisciplinary project teams, which may include clinical and other technical experts, to develop products throughout their life cycle. 
• ·       Act as a subject matter expert and help the team members with day-to-day trouble shooting activities, presenting solutions to project related problems.
• ·       Prepare estimates for conducting regulatory services as part of single or multiple service proposals.
• ·       Support meetings with clients to discuss proposals, the status of ongoing projects, and as part of general business development activities.
• ·       Ensure compliance with appropriate global regulatory requirements and the company’s policies and processes.
• ·       Prepare training materials and share best practices in the regulatory area, both internally and externally.
• ·       Participate as regulatory support in internal or external project audits.
• ·       Participate as regulatory support on internal cross-functional initiatives.
• ·       Contribute to the creation and/or maintenance of SOPs and other process related documentation as required.
• ·       Provide support in oversight to team members in the execution of their project responsibilities.
• ·       Capable of identifying when to ensure line support required to provide additional guidance and direction.
• ·       Maintenance of individual training records (Syneos Health or client related) and completion of all designated required training.

QUALIFICATION REQUIREMENTS

BS or PhD degree, preferably in a science-related field or equivalent experience in science/regulatory/medical writing-related field. Moderate pharmaceutical/medical device related experience.
Demonstrated experience in contributing to the preparation of regulatory submissions including, for example CE marking, MDR update, Response to NB queries including electronic submissions.
Excellent interpersonal / communication skills including excellent written and verbal communication skills.
Excellent customer service skills, with the ability to work both as a team member and independently.
Good quality management skills.
Advanced skills in Microsoft Office Applications
Ability to interact with staff from multiple departments and offices to establish project standards.
Good initiative, adaptability, and pro-activity.
Strong analytical skills, good attention to detail.
Ability to work concurrently on projects, each with specific instructions that may differ from project to project.
Fluent in speaking, writing, and reading English.

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