Senior Regulatory Affairs Specialist

Descripci??n del empleo Who we wantSelf-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.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.Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.What you will do The Senior Regulatory Affairs Specialist works to bring medical devices to market and ensures ongoing compliance. Participates on cross-functional teams, develops global regulatory strategies, authors regulatory submissions, interacts with regulatory agencies/notified bodies, reviews labeling and marketing materials, and evaluates proposed device changes. Responsibilities: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 complianceAnticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutionsIdentifies 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 changesEvaluates proposed products for regulatory classification and jurisdictionDetermines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activitiesProvides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organizationCompares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomesNegotiates with regulatory authorities throughout the product lifecycleIdentifies the need for new regulatory procedures, SOPs, and participates in development and implementationHelps train stakeholders on current and new regulatory requirements to ensure organization-wide complianceAssists other departments in the development of SOPs to ensure regulatory complianceProvides regulatory input and technical guidance on global regulatory requirements to product development teamsAdvises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulationsAssesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulationsEvaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissionsProvides knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationshipsIdentifies, monitors, and submits applicable reports or notifications to regulatory authorities during the clinical research processProvides regulatory information and guidance for proposed product claims/labelingEnsures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claimsPrepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelinesMonitors the progress of the regulatory authority review process through appropriate communications with the agencyCommunicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication toolsWorks with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committeesWhat you needBachelor's degree required; Engineering, Science or relatedMS in Regulatory Science preferredMS and/or RAC desired3+ years of related experience requiredExperience drafting 510(k)s preferredWork From Home: YesTravel Percentage: Up to 25%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.
Who we want Tipo de empleado:

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

Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.

Lugar:

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

Tipo de empleo:

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.

Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.

What you will do The Senior Regulatory Affairs Specialist works to bring medical devices to market and ensures ongoing compliance. Participates on cross-functional teams, develops global regulatory strategies, authors regulatory submissions, interacts with regulatory agencies/notified bodies, reviews labeling and marketing materials, and evaluates proposed device changes.
Responsibilities:

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

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