Senior Regulatory Affairs Specialist (Hybrid)

Stryker Corporation; Redmond (WA); Sur place; USD 96 000 - 160 000; Plein temps

Résumé du poste

Stryker Corporation in Redmond, WA is seeking a Senior Regulatory Affairs Specialist to support compliance and market access of medical devices throughout their lifecycle. You will partner with cross-functional teams to manage regulatory activities and submissions for product changes.

Ideal candidates have at least 2 years in regulatory affairs, experience with FDA regulations, and a RAC or advanced degree.

Qualifications

• Bachelor’s degree required.
• Minimum of 2 years in a Regulatory Affairs role.
• Experience in an FDA or highly regulated industry required.
• RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.

Responsabilités

• Support regulatory assessments of proposed changes or product transfers with R&D, Marketing and Manufacturing teams.
• Identify requirements and obstacles for market access and distribution.
• Develop and update regulatory strategy based on regulatory changes.
• Evaluate regulatory classification and jurisdiction for proposed products.
• Determine requirements and options for regulatory submissions and compliance activities.
• Prepare and submit regulatory submissions per applicable requirements.
• Provide regulatory guidance for product development and planning throughout lifecycle.
• Communicate with regulatory authorities during submissions and reviews.
• Evaluate changes for filing solutions and plan non-submission changes.
• Monitor and submit reports to regulatory authorities during clinical processes.
• Maintain current product registrations and assist with registration changes.

Connaissances

Regulatory affairs

FDA regulations

SaMD knowledge

Formation

Bachelor's degree in Engineering/Science/Regulatory Affairs

Description du poste

Work Flexibility: Hybrid Join Stryker's Medical Division supporting Emergency Care | Stryker as a Senior Regulatory Affairs Specialist based in Redmond, Washington (Hybrid). In this role, you will support the continued compliance, registration, and market availability of medical devices throughout their lifecycle by partnering with cross-functional teams on product changes and regulatory activities.

What you will do

• Support R&D, Marketing and Manufacturing teams with regulatory assessments of proposed changes or product transfers.
• Identify requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.).
• Assist in the development of regulatory strategy and updates strategy based upon regulatory changes.
• Evaluate proposed products for regulatory classification and jurisdiction.
• Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities.
• Prepare and submit electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines for required products.
• Provide regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization.
• Communicate and interact with regulatory authorities throughout the development and review process of a regulatory submission through appropriate communication tools.
• Evaluate proposed pre-clinical, clinical, and manufacturing changes for regulatory filing solutions and propose plans/strategies (if appropriate) for changes that do not require submissions.
• Identify, monitor, and submit applicable reports or notifications to regulatory authorities during the clinical research process.
• Maintain current product registrations and assist with processing registration changes when required.

What you need

• Bachelor’s degree required.
• Preferred to be in Engineering, Science, Regulatory Affairs, or a related technical field.
• Minimum of 2 years in a Regulatory Affairs role required.
• Experience in an FDA or highly regulated industry required.
• Preferred Experience supporting Software as a Medical Device (SaMD) products or software-enabled technologies within a regulated industry.
• RAC certification or Advanced Degree (Masters in Regulatory Affairs).
• Previous experience with Class II/III medical devices.
• Experience authoring regulatory submissions for product approval.
• Experience interacting with regulatory agencies.

US15: $95,800 - $159,600 USD Annual View the U.S. work location and transparency guide to find the pay range for your location.

Travel Percentage: 0%

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.

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com

Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.