Senior Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist
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$ 84900 - 136100
1 Vacancy
Job Description
Stryker is hiring aSenior Regulatory Affairs Specialistto support Sports Medicine in Denver CO! In this role you will develop and implement regulatory strategies ensure compliance across the product lifecycle manage regulatory submissions advise stakeholders on regulatory requirements and engage with regulatory authorities to resolve issues and support market access!
What you will do:
Develops and updates local regional and global regulatory strategies based on regulatory intelligence and emerging changes.
Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g. concept development manufacturing marketing) to ensure product compliance
Identifies regulatory obstacles anticipates emerging issues and proposes solutions or refinements based on regulatory outcomes
Identifies requirements and potential obstacles for market access distribution (federal provincial/territorial state reimbursement purchasing groups etc.
Evaluates product classification and determines regulatory submission requirements approval pathways and compliance options at local national and international levels preparing and submitting both electronic and paper regulatory filings in line with applicable guidelines.
Provides regulatory guidance and technical input throughout the product lifecycle ensuring compliance with global regulatory requirements.
Develops and implements new regulatory procedures and SOPs and provides training to stakeholders to ensure compliance across the organization.
Assesses the acceptability of quality preclinical and clinical documents for submission and ensures compliance with regulations
Evaluates proposed preclinical clinical and manufacturing changes for regulatory filing solutions and proposes plans/strategizes for changes that do not require submissions
Provides knowledge and guidance on preapproval inspections GCP inspections and clinical investigator relationships
Engages and negotiates with regulatory authorities throughout the product lifecycle ensuring effective communication monitoring submission progress and submitting applicable reports or notifications 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
What you need:
Required:
BS in Engineering Science or related degree; or MS in Regulatory Science
2 years of related experience i. preparing and submitting regulatory filings regulatory compliance interacting with regulatory authorities etc.
Preferred:
MS in Regulatory Science or RACs preferred
Project management writing coordination and of regulatory items
Perform technical and scientific regulatory activities
Works on broad assignments that require creative thinking originality and innovative problemsolving
$84900 $136100 salary plus bonus eligible benefits. Actual minimum and maximum may vary based on pay is based on skills experience and other relevant factors.
Travel Percentage: 10Stryker 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 contractors legal duty to furnish information.Required Experience:
Senior IC
Employment Type
Full-Time
