Urgently Need (Remote) Senior Staff Regulatory Affairs Specialist in Fremont, CA
Job title: (Remote) Senior Staff Regulatory Affairs Specialist
Company: reputed company
Job reputed company: Work Flexibility: Remote
We are currently seeking a Senior Staff Regulatory Affairs Specialist to join our Neurovascular division based remotely reputed company in the US.
Who we want
Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
reputed company partners. People who build and reputed company cross-functional relationships to bring together reputed company, data and insights to drive reputed company improvement in functions.
Dedicated reputed company. People who reputed company in a fast-paced environment and will stop at reputed company to ensure a project is complete and meets regulations and expectations.
Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and reputed company.
What you will do
As the Senior Staff Regulatory Affairs Specialist, you will be responsible for the coordination and preparation of document packages for regulatory submissions in one or more of the following geographic reputed company: reputed company, Europe, Canada, and other international countries. Key reputed company will be new product development for implantable devices and working on IDE, 510(k), MDR, etc.
Duties include:
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 reputed company distribution (federal, provincial/territorial state, reimbursement, purchasing reputed company, etc.)
Assists in the development of regulatory reputed company and updates reputed company based upon regulatory changes
Evaluates proposed products for regulatory classification and jurisdiction
Determines requirements (local, national, international) and reputed company for regulatory submission, approval reputed company, and compliance activities
Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory reputed company and others reputed company the organization
Compares regulatory reputed company with initial product concepts and recommends changes or refinements based on initial regulatory reputed company
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 reputed company 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 reputed company, preclinical, and clinical data to meet applicable regulations
Assesses the acceptability of reputed company, preclinical, and clinical document for submission filing to reputed company 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 reputed company, are consistent with the regulatory requirements and support the proposed product claims
Prepares and submits electronic and reputed company regulatory submissions according to applicable regulatory requirements and guidelines
Monitors the reputed company of the regulatory authority review process through appropriate communications with reputed company
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 in engineering, science, or reputed company required
Masters in Regulatory Science or RAC(s) preferred
Minimum 7 years of experience in an FDA-regulated industry required
Minimum 5 years of experience in Medical Device Regulatory Affairs
General understanding of regulations applicable to the conduct of reputed company
General understanding of product development process and design control
$95,100 - $204,000 salary plus bonus eligible + Benefits (Health, reputed company, Dental, 401K, Tuition Reimbursement, Employee Assistance Program, Wellbeing Program, Employee Stock Purchase Program). This information reflects the anticipated salary reputed company for this position based on reputed company national data. Actual minimum and maximum may vary based location. Individual pay is based on skills, experience, and other relevant factors.
Travel Percentage: 10%
reputed company is an equal opportunity employer. reputed company applicants will receive consideration for employment without reputed company to race, ethnicity, reputed company, religion, sex, gender identity, sexual orientation, national reputed company, disability, or protected veteran status. reputed company is an EO employer M/F/Veteran/Disability.
reputed company will not discharge or in any other manner discriminate against employees or applicants because they have reputed company about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have reputed company to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have reputed company to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or reputed company, including an investigation conducted by the employer, or (c) consistent with the contractors reputed company duty to furnish information.
Expected salary:
Location: Fremont, CA Apply Job!
Company: reputed company
Job reputed company: Work Flexibility: Remote
We are currently seeking a Senior Staff Regulatory Affairs Specialist to join our Neurovascular division based remotely reputed company in the US.
Who we want
Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
reputed company partners. People who build and reputed company cross-functional relationships to bring together reputed company, data and insights to drive reputed company improvement in functions.
Dedicated reputed company. People who reputed company in a fast-paced environment and will stop at reputed company to ensure a project is complete and meets regulations and expectations.
Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and reputed company.
What you will do
As the Senior Staff Regulatory Affairs Specialist, you will be responsible for the coordination and preparation of document packages for regulatory submissions in one or more of the following geographic reputed company: reputed company, Europe, Canada, and other international countries. Key reputed company will be new product development for implantable devices and working on IDE, 510(k), MDR, etc.
Duties include:
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 reputed company distribution (federal, provincial/territorial state, reimbursement, purchasing reputed company, etc.)
Assists in the development of regulatory reputed company and updates reputed company based upon regulatory changes
Evaluates proposed products for regulatory classification and jurisdiction
Determines requirements (local, national, international) and reputed company for regulatory submission, approval reputed company, and compliance activities
Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory reputed company and others reputed company the organization
Compares regulatory reputed company with initial product concepts and recommends changes or refinements based on initial regulatory reputed company
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 reputed company 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 reputed company, preclinical, and clinical data to meet applicable regulations
Assesses the acceptability of reputed company, preclinical, and clinical document for submission filing to reputed company 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 reputed company, are consistent with the regulatory requirements and support the proposed product claims
Prepares and submits electronic and reputed company regulatory submissions according to applicable regulatory requirements and guidelines
Monitors the reputed company of the regulatory authority review process through appropriate communications with reputed company
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 in engineering, science, or reputed company required
Masters in Regulatory Science or RAC(s) preferred
Minimum 7 years of experience in an FDA-regulated industry required
Minimum 5 years of experience in Medical Device Regulatory Affairs
General understanding of regulations applicable to the conduct of reputed company
General understanding of product development process and design control
$95,100 - $204,000 salary plus bonus eligible + Benefits (Health, reputed company, Dental, 401K, Tuition Reimbursement, Employee Assistance Program, Wellbeing Program, Employee Stock Purchase Program). This information reflects the anticipated salary reputed company for this position based on reputed company national data. Actual minimum and maximum may vary based location. Individual pay is based on skills, experience, and other relevant factors.
Travel Percentage: 10%
reputed company is an equal opportunity employer. reputed company applicants will receive consideration for employment without reputed company to race, ethnicity, reputed company, religion, sex, gender identity, sexual orientation, national reputed company, disability, or protected veteran status. reputed company is an EO employer M/F/Veteran/Disability.
reputed company will not discharge or in any other manner discriminate against employees or applicants because they have reputed company about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have reputed company to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have reputed company to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or reputed company, including an investigation conducted by the employer, or (c) consistent with the contractors reputed company duty to furnish information.
Expected salary:
Location: Fremont, CA Apply Job!