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Job Details
Why RA/QA at Stryker? Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the World’s Best Workplaces, apply now ! Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com 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.
- 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.
- 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)
- 12 paid holidays annually
- 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.
About the Company
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers... Read more