Regulatory Affairs Specialist with EU MDR
  • Santa Clara, California, US
  • +914043515100
543 Days ago
Job Description

Position Name: Regulatory Affairs Specialist with EU MDR

Location: Menlo Park, CA and Santa Clara, CA (1 position for each location)

Duration: Full Time with HCL America

Salary: $45/hr on W2 - $50/hr on W2 + HCL Benefits

 

Responsibilities:

·         Responsible for implementing and maintaining the effectiveness of the quality system.

·         Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

·         Provide regulatory input to product lifecycle planning

·         Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management

·         Assist in the development of multi country regulatory strategy and update strategy based upon regulatory changes

·         Assist in regulatory due diligence for potential and new acquisitions

·         Utilize technical regulatory skills to propose strategies on complex issues

·         Determine submission and approval requirements

·         Monitor trade association positions for impact on company products

·         Anticipate and identify regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams

·         Recruit; develop and mentor regulatory professionals

·         Assess the acceptability of quality; pre-clinical and clinical documentation for submission filing

·         Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical phases and recommend solutions

·         Compile; prepare; review and submit regulatory submission to authorities

·         Monitor impact of changing regulations on submission strategies and update internal stakeholders

·         Monitor applications under regulatory review

·         Oversee processes involved with maintaining annual licenses; registrations; listings and patent information

·         Ensure compliance with product post marketing approval requirements

·         Develop; implement and manage appropriate SOPs and systems to track and manage product-associated events

·         Actively contribute to the development and functioning of the crisis/issue management program

·         Provide regulatory input for product recalls and recall communications

·         Report adverse events to regulatory agencies and internal stakeholders

·         Review and approve advertising and promotional items to ensure regulatory compliance

Thanks & Regards

Jay Prakash Thakur
Premium Information Technology, Inc.
856-242-6588 (Work)
856-637-2408 (Cell)
856-228-3014 (Fax)
Email: jay@premiuminfotech.com
www.premiuminfotech.com
(A registered user of
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Industry
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Required Skills
  • Regulatory Affairs Specialist with EU MDR

Experience
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Salary
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Working Hours / Week
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