Senior Staff Regulatory Affairs Specialist (Hybrid)

Work Flexibility : Hybrid

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 .

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.

Travel Percentage : 20%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status.

Stryker is an EO employer M / F / Veteran / Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.

However, employees who have access 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 access 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 action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.