Urgently Need (Remote) Senior Staff Regulatory Affairs Specialist in Fremont, CA

Job title: (Remote) Senior Staff Regulatory Affairs Specialist

Company: Stryker

Job description: Work Flexibility: Remote



We are currently seeking a Senior Staff Regulatory Affairs Specialist to join our Neurovascular division based remotely anywhere 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.



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



Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing 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 outcomes.



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 regions: United States, Europe, Canada, and other international countries. Key focus 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 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



Bachelor’s Degree in engineering, science, or related 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 clinical trials



General understanding of product development process and design control



$95,100 - $204,000 salary plus bonus eligible + Benefits (Health, Vision, Dental, 401K, Tuition Reimbursement, Employee Assistance Program, Wellbeing Program, Employee Stock Purchase Program). This information reflects the anticipated salary range for this position based on current national data. Actual minimum and maximum may vary based location. Individual pay is based on skills, experience, and other relevant factors.



Travel Percentage: 10%



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.

Expected salary:

Location: Fremont, CA

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