Senior Regulatory Affairs Specialist

Regulatory Jobs; Redmond (WA); Hybrid; USD 96,000 - 160,000; Full time

Job summary

Stryker's Medical Division in Redmond, Washington (Hybrid) seeks a Senior Regulatory Affairs Specialist to help ensure compliance, registration, and market availability of medical devices throughout their lifecycle. You will collaborate with R&D, Marketing, and Manufacturing to address regulatory changes, filings, and strategy while engaging with authorities as needed.

The role requires a Bachelor's degree, at least 2 years in Regulatory Affairs, and experience in a highly regulated setting such

Qualifications

• Bachelor’s degree in Engineering, Science, Regulatory Affairs, or a related technical field.
• Minimum of 2 years in a Regulatory Affairs role.
• Experience in an FDA or highly regulated industry.

Responsibilities

• Support R&D, Marketing and Manufacturing teams with regulatory assessments of proposed changes or product transfers.
• Identify requirements and obstacles for market access distribution (federal, provincial/state, reimbursement, purchasing groups, etc.).
• Assist in developing regulatory strategy and updates to reflect regulatory changes.
• Evaluate proposed products for regulatory classification and jurisdiction.
• Determine requirements and options for regulatory submissions, approval pathways, and compliance activities.
• Prepare and submit electronic and paper regulatory submissions per applicable requirements.
• Provide regulatory information and guidance for product development and planning throughout the lifecycle.
• Communicate with regulatory authorities during the development and review process of submissions.
• Evaluate changes for filing solutions and propose plans for non-submission changes.
• Identify, monitor, and submit reports or notifications to regulatory authorities during clinical processes.
• Maintain current product registrations and assist with registration changes when required.

Skills

Regulatory affairs

FDA regulatory experience

SaMD experience

Medical device regulatory knowledge

Education

Bachelor's degree

Job description

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

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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.