Job Description

We are currently seeking a Senior Staff Regulatory Affairs Specialist to join our Endoscopy division based hybrid on-site three days per week in San Jose, CA.

Who we want

·          Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations. 

·          Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

·          Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data, and insights to drive continuous improvement in functions.

What you will do

As the Senior Staff Regulatory Affairs Specialist , you will play an integral role on our Open Field Visualization premarket regulatory team, specifically supporting business development activities, actively participating in the integration of Regulatory roles and responsibilities for newly acquired technology MOLLI Surgical . You will be responsible for supporting the entire product lifecycle by supporting new product development, assessing design changes to determine global regulatory impact, and completing actions to maintain regulatory compliance.  

• Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies   

• Participates in advocacy activities of a more advanced technical and/or tactical or strategic nature   

• Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance

• Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions

• Identifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)

• Assists in the development of regulatory strategy and updates strategy based upon regulatory changes

• Evaluates proposed products for regulatory classification and jurisdiction

• Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities

• Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization 

• Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes

• Negotiates with regulatory authorities throughout the product lifecycle

• Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation

• Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance

• Assists other departments in the development of SOPs to ensure regulatory compliance

• Provides regulatory input and technical guidance on global regulatory requirements to product development teams

• Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations

• Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations

• Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions

• Provides knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships

• Identifies, monitors, and submits applicable reports or notifications to regulatory authorities during the clinical research process

• Provides regulatory information and guidance for proposed product claims/labeling

• Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims

• Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines

• Monitors the progress of the regulatory authority review process through appropriate communications with the agency

• Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools

• Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees

What you need

• Bachelors Degree required; preferably in Engineering, Science, or related area

• RAC preferred                               

• Minimum 6 years of full-time work experience in an FDA regulated environment required

• Minimum 4 years of full-time work experience in medical device regulatory affairs required

• Demonstrated applied knowledge of FDA and international medical device regulations/standards (e.g. EU MDR)

$127,400 - $210,100 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.

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