Software Regulatory Affairs Specialist (Senior Staff Level) (Hybrid)

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 qualified Senior StaffRegulatory Affairs Specialist(Software) to join Stryker’s Surgical Technologies business at our Instruments division based hybrid in Portage, MI. Stryker’s Surgical Technologies business delivers innovative products and services for the surgical operating room ecosystem.

Who we want

·         Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations. 

·         Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

·         Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

As a Senior Staff Regulatory Affairs Specialist (Software), you will set Global Regulatory strategy for new product development. The portfolio assigned will be heavy in software, AI, machine learning, connectivity, cloud-based services, and electrical device experience. Check out this link to learn more about this Business Unit! https://www.stryker.com/us/en/surgical-technologies.html 

In this role, you will support FDA 510(k) premarket notifications and submissions. You will have the opportunity to directly interact with FDA on premarket submissions and during post-market audits. You will sit directly at the table with cross-functional new product development teams and advise them towards successful and least burdensome launches. You will act as a steward for Regulatory and a key partner with the business. Imagine setting your own RA strategy, not inheriting one, and seeing the device portfolio stand on your strategy for years to come! This is a unique opportunity to create a legacy.

• Provides regulatory information and guidance throughout the product and software development lifecycle including advising on unique regulatory and submission requirements for software as a medical device (SaMD), software in a medical device (SiMD), cybersecurity and machine learning.

• Assists in the development and update of regulatory strategy and SOPs

• Provides regulatory input for new product development and product lifecycle planning

• Evaluates regulatory impact of proposed changes to launched products

• Maintains annual licenses, registrations and listings

• Reviews regulatory aspects of contracts

• Ensures compliance with product post-approval or clearance requirements

• Approves labeling, advertising and promotional items for compliance

• Reviews publicly disseminated information to minimize regulatory exposure

• Reviews product claims and preserving confidentiality of applicable product information

• Provides regulatory input for and appropriate follow-up to inspections and audits

• Assits in the development and implementation of SOPs and systems to track and manage product-associated events

• Advises responsible personnel on regulatory requirements for quality, preclinical and clinical data requirements for clinical study or marketing applications

• Evaluates proposed preclinical, clinical and manufacturing changes for regulatory filing strategies

• Assessing the acceptability of quality, preclinical and clinical documentation for submission to comply with regulatory requirements

• Monitors impact of changing regulations on submission strategies and identifying issues early in the submission preparation process that could impact product launch

• Compiles, prepares, reviews, and submits regulatory dossiers to authorities

• Participates in negotiations and interactions with regulatory authorities during the development and review process to ensure submission approval/clearance

What you need

• Bachelor’s Degree (B.S. or B.A.) in Science, Engineering, Computer Engineering or equivalent focus required.

• 7 years of work experience in an FDA or highly regulated industry required.

• Relevant work experience with medical devices including Software in Medical Device (SiMD) required and/or Software as Medical Device (SaMD) preferred.

• A minimum of 2-5 years in a Regulatory Affairs role required.

• Previous experience with Class II/III medical devices preferred.

• Experience with regulatory submissions for product approval preferred.

• Ability to comply with constantly changing regulatory procedures and prioritize work effectively.

Our benefits:

• 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.

For a more detailed overview of our benefits or time off, please follow this link to learn more: US Stryker employee benefits
About Stryker
Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at stryker.com.
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Stryker is driven to work together with our customers to make healthcare better. Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, to obtain various vaccinations as an essential function of their role.