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Job Details


Stryker

Senior Staff Regulatory Affairs Specialist (Remote) (R456293)

Equipment/Technology Specialist

Equipment and Facilities Specialist

Yearly

No

Denver, Colorado, United States

COVID-19 vaccination requirements

Stryker is driven to work together with our customers to make healthcare better. In order to fulfill our commitment as a federal contractor, while focusing on the health and safety of our employees and those that we serve, COVID-19 vaccines will be required for all Stryker US employees effective January 4, 2022, as well as all new US employees joining our company. Fully vaccinated persons are those who are >=14 days post-completion of the primary series of an FDA-authorized COVID-19 vaccine. If you are applying to a sales and field role which requires access to customer accounts as a function of your job, you may be required, depending on customer requirements, to obtain the COVID-19 vaccination before the January 4 effective date of Stryker's vaccine policy. For more information, please visit our COVID-19 Vaccination Requirements FAQs page.

Why join Stryker?

We are proud to be named one 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

Our benefits include bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; paid time off plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards – not to mention various social and recreational activities.

Why regulatory affairs/quality assurance 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 Regulatory Affairs team the opportunity to learn new things, as well as endless growth opportunities.

Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team


We are currently seeking a Senior Staff Regulatory Affairs Specialist to join our Sports Medicine Division to be based in Denver, Colorado or remotely anywhere within the United States.

Who we want

  • Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.

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

  • Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

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

  • Motivated product launchers. People who bring strategic direction and drive for execution to ensure products are developed and launched with precision.

  • Business-oriented evaluators. People who effectively interpret information to demonstrate the effects of business initiatives, regulation and industry trends for sales, management and leadership teams.

What you will do

As the Sports Medicine Senior Staff Regulatory Affairs Specialist, you will support both product development activities for both US and OUS global regulatory release by contributing to the development and updating of regulatory strategies, with a focus on our portfolio of patient-specific surgical planning software. Lean more about the product you’ll be supporting on our website (link). You will support the entire product lifecycle by assessing post-launch changes to determine the global regulatory impact of changes. You will ensure regulatory compliance by completing thorough assessments and completing the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other global regulatory bodies. You will also identify information sources and resources for staying informed of changing local, regional, and global regulations.

  • Address and advise teams on appropriate pathways to market under the supervision of more experienced regulatory professionals.

  • Participate on product development and sustaining engineering teams to ensure appropriate global regulatory requirements are incorporated as part of the development and design change process.

  • Author submissions and other regulatory documents to obtain approval to bring new or modified products to market.

  • Apply software and security (i.e., cybersecurity, AI/ML) regulatory standards, guidance documents, and industry expectations to product strategies and submissions.

  • Interact across the corporation or in industry settings to influence software, interoperability and cybersecurity related regulatory items.

  • Support marketing, R&D and manufacturing teams in regulatory assessment of proposed changes or product transfers; review and approve document action requests.

  • Interface and coordinate with the FDA, Notified Bodies, Competent Authorities and other regulatory agencies on submissions, approvals or other issues under the supervision of more experienced regulatory professionals.

  • Establish and maintain regulatory information systems both electronically.

  • Interpret existing and/or new regulatory requirements as they relate to company products and procedures. Communicate this to appropriate personnel.

  • Conduct labeling, marketing, product transfer and literature review pre and post market under the supervision of a more experienced regulatory professional.

  • Assist the RA Managers and others with the development, implementation and maintenance of regulatory SOP's.

What you need

  • A minimum of 7 years of experience in a regulated industry required; preferably within medical devices.

  • A minimum of 3 years of Regulatory Affairs experience required.

  • General understanding of product development process and design control.

  • General understanding of regulations applicable to the conduct of clinical trials.

  • Thorough understanding of FDA and international medical device regulations.

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

  • Previous experience with 510(k)s highly preferred.

  • Experience drafting regulatory submissions for product approval required.

  • Experience interacting with regulatory agencies required.

If this role is filled within Colorado this is the salary range, other locations may have alternative salary ranges; $83,700 - $137,200 salary plus min 8%- max 14% bonus potential. + benefits.


Know someone at Stryker?

Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program at https://careers.stryker.com/referrals/

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.

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