Stryker is one of the world's leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Senior Staff Regulatory Affairs Specialist, Software Interoperability to join our Endsoscopy division in San Jose, CA or remotely anywhere within the US. .
Who we want
- Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
- Dedicated achievers. People who thrive in a fast-paced environment and will stop atnothing to ensure a project is complete and meets regulations and expectations.
- Collaborative partners. People who build and leverage cross-functional relationships tobring together ideas, data and insights to drive continuous improvement in functions.
- Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
What you will do
As the Senior Staff Regulatory Affairs Specialist, Software Interoperability you will ensure regulatory compliance by completing thorough assessments and the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory bodies. Focuses on products with software and/or interoperability with other devices or external networks.
- Prepare complex submissions to gain global approvals for clinical research, export, and commercial distribution, such as: IDE, 510(k), PMA, Shonin, Design Dossier and Technical File.
- Apply software and security (i.e., cybersecurity) regulatory standards, guidance documents, and industry expectations to product strategies and submissions. Guides others in the organization who are working on similar products.
- Interact across corporation or in industry settings to influence software, interoperability and cybersecurity related regulatory items.
- Demonstrate knowledge and skills in areas of regulatory pathways, risk-benefit analysis, communication and collaboration internally and external, submission, registration, obtaining approval/clearance, documentation, post marketing compliance.
- Demonstrate strong project management, writing, coordination, and execution of regulatory items, with emphasis on technical and scientific regulatory activities.
- Possess and apply a broad and advanced knowledge, skills/abilities and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures.
- Develop and maintain positive relationships with regulatory agencies through oral and written communications regarding pre-submissions strategies, potential regulatory pathways, compliance test requirements, clarification, and follow-up of submissions under review.
- Lead negotiations and interactions with regulatory authorities during the development and review process to ensure submission approval/clearance.
- Advise personnel on regulatory requirements for quality, preclinical and clinical data requirements for clinical study applications or marketing applications.
- Provide regulatory input to product lifecycle planning.
- Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions.
- Review of advertising and promotional items.
- Assist in SOP development and review.
What you need
- A Bachelor's Degree (B.S or B.A) in Engineering, Science or equivalent focus is required.
- A minimum of 7 years of experience in an FDA regulated industry.
- A minimum of 5 years of Regulatory Affairs experience.
- Software-related regulatory experience required (e.g., IEC62304, FDA Software/Cybersecurity Guidance Documents)
- RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.
- Ability to understand and explain detailed regulatory compliance programs and/or issues.
- Ability to comply with constantly changing regulatory procedures and prioritize workeffectively.
- Ability to analyze and resolve non-routine regulatory issues using independent judgment.
- Excellent analytical and writing skills.
- Excellent interpersonal, written and oral communication skills.
- Effective organizational skills.
- Advanced PC skills with proficiency in Microsoft office Suite, including Excel.
Work From Home: NoTravel Percentage: Up to 25%