Job Information
Stryker Senior Staff Regulatory Affairs Specialist (Remote - Pacific time zone) in Fremont, California
We are excited to be named one of the World’s Best Workplaces by Fortune Magazine! We are proud to offer you 12 paid holidays annually, as well other great perks. For an overview of our benefits and time off, please follow this link to learn more: US Stryker employee benefits. (https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf)
We are currently seeking a Senior Staff Regulatory Affairs Specialist to join our Neurovascular division based remote anywhere within the Pacific time zone.
Who we want
Strategic. Creates alternative ways to proceed. Faced with any given scenario, can quickly spot the relevant patterns and issues.
Achievers. Thrives on accomplishing tasks and constantly driven to do more.
Collaborators. Collaborates and builds relationships with internal and external stakeholders.
Communicators. Articulates well and expresses ideas effectively.
Learners. Great desire to learn and looks to continuously improve.
What you will do
As the Senior Staff Regulatory Affairs Specialist , you will be core team member of new product development team and review advertising and promotional materials. This critical role advises project and/or product development teams on, and to ensure compliance with, applicable global regulatory requirements. You will be responsible for regulatory agency communications regarding pre-submission strategies/ regulatory pathway development and submission. You will also collaborate with Legal, Marketing and other stakeholders to review advertising and promotional materials.
Lead the business unit in development of processes/procedures for and implementation of new or revised regulatory requirements.
Partner regularly with marketing, engineering, clinical and quality on project and product development teams.
Provide strategic direction on how to best streamline department processes (i.e. global regulatory submissions and registrations)
Serve as a regulatory affairs representative to improve awareness, visibility, and communication on regulatory requirements to support company goals and priorities.
Prepares complex submissions to gain approvals for clinical research, export, and commercial distribution, such as: IDE, IDES, IDE Progress Report, Clinical Trial Submission [OUS], 510(k), PMA, PMA Annual Report, HDE, HDE Annual Report, Shonin, PLA, CE-Mark Design Dossier, CE-Mark Technical File, Intercontinental Dossiers, Certificates to Foreign Government. Ensures that existing approvals and documentation are maintained. Communicates with in-country RA personnel to facilitate global clearances/approvals.
Develops global regulatory strategies for project teams. Provides input on and reviews protocols and reports for: design verification, design validation, shelf life, pre-clinical studies, and clinical studies. Monitors, researches and obtains information [via FOI] on FDA clearances/approvals of competitors, and proactively shares this information.
For new, routine or ongoing issues, communicates with regulatory agencies. Prepares for meetings with regulatory agencies and investigators.
Mentors others on a regular basis. Is not expected to supervise others.
Evaluates and approves proposed changes to products and controlled documents; develops, approves, and implements global regulatory action plans based on the changes. Organizes and maintains RA files.
Reviews and approves labeling (Instructions for Use, labels, promotional materials) for compliance to: standards, guidelines, regulations, and regulatory approvals/clearances.
Provides regulatory support to other Stryker personnel to facilitate cross-divisional leverage.
Analyzes existing systems and procedures, recommends solutions/improvements, and writes Work Instructions, SOPs, and SLPs as needed to support departmental functions and Stryker’s Quality System. Prepares and delivers training programs to the department and other functional groups to ensure compliance.
Understands: biocompatibility requirements, CMDRs, Design Control, Medical Device Directive, Essential Requirements, ISO 13485 , labeling requirements, Quality System Regulation, export requirements, and regulatory requirements of pertinent regions. Monitors changes in the regulatory environment, evaluates impact, and communicates to interested parties.
Uses existing project management tools, and develops/implements new tools as needed.
Performs responsibilities required by the Quality System and other duties as assigned or requested.
What you need
Bachelor’s Degree (B.S. or B.A.) required; preferably in Engineering, Science or related discipline
7+ years’ experience in an FDA regulated environment required
5+ years’ experience in medical device regulatory affairs required
RAC certification or Advance Degree (Master in Regulatory Affairs) strongly preferred
Demonstrated applied knowledge of FDA and international medical device regulations/standards (e.g. EU MDR)
$98,000.00 - $210,100.00 USD 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.