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... more details
Work Flexibility: Hybrid
We are currently seeking a Senior Staff Regulatory Affairs Specialist to join our Neurovascular division based hybrid in Fremont, CA.
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)
$127,400.00 - $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.
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.
