Senior Regulatory Affairs Specialist (Hybrid) - California, Fremont 47900 Bayside Pkwy

Work Flexibility: Hybrid

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.

Travel Percentage: 10%

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.