Senior Regulatory Affairs Specialist (Hybrid)_

Fremont

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We are currently seeking a **Senior Regulatory Affairs Specialist** to join Stryker Neurovascular’s International Regulatory Affairs team. This role is based hybrid in Fremont, California.

**Who we want**

**Strategic.** Creates alternative ways to proceed. Faced with any given scenario, can quickly spot the relevant patterns and issues.

**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.

**Communicators.** Articulates well and expresses ideas effectively.

**Learners.** Great desire to learn and looks to continuously improve.

**Teammates** . Supports, encourages, and inspires others.

**What you will do**

As the **Senior Regulatory Affairs Specialist** , you will operate in a fast-paced environment and liaise with internal customers and external regulatory authorities to maintain regulatory compliance of Stryker Neurovascular products globally.

+ Serves as the primary point of contact between the RA Int’l project team and other stakeholders such as RA Domestic, Clinical Affairs, Marketing, PMO, QA, Supply Chain, and others in regard to program/project assigned.

+ Collaborating with internal teams, including R&D, manufacturing, and marketing, to ensure that regulatory requirements are integrated into project plans and timelines.

+ Develop a centralized international regulatory requirements matrix regarding OEMs and CMs as well as establishing a communication channel with each document source/originator ensuring RA Int’l fulfills in an organized and timely manner such requirements.

+ 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.)

+ Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities.

+ Evaluate, identify and disseminate within RA Int’l lessons learned, success cases that could be beneficial across regions related to pre-submission strategy, regulatory advocacy and/or market clearance as a way to leverage internal RA Int’l good practices.

+ Gather change notices (CNs) supporting documentation in an organized and sustained manner to be provided to RA International teams for regulatory submissions as applicable. In addition, identify potential causes of documentation and change control process rework delays and implement streamlining process improvement actions.

+ Provides regulatory support to other RA Int’l special projects (platform implementation as ADO, RIMs, etc.) to facilitate cross-functional leverage and regulatory deliverables.

+ Analyzes existing systems and procedures, recommends solutions/improvements, and writes Work Instructions and SOPs (as needed), to support departmental functions and Stryker’s Quality Management System. Prepares and delivers training programs to the department and other functional groups to ensure compliance.

+ Uses existing project management and data analysis tools and develops/implements new tools as needed.

+ Managing timelines, budgets, and resources to ensure that regulatory objectives are achieved within specified deadlines and constraints.

+ 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.

$97,900.00 - $156,900.00 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

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.