Regulatory Affairs

Client Abbott

Position: Regulatory Affairs

Location Santa Clara, CA

Duration: Contract / Full-time with HCL

Keywords: Regulatory affairs, RA with CE and international experience, Project management skill is preferred, US and EU submissions including PMA, 510k, IDE, medical device Industry exp.

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