Staff Post Market Regulatory Specialist

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 the #5 World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com

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. 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 team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

We are currently seeking a Staff Post Market Regulatory Specialist to join our Joint Replacement Division to be based in Weston, FL or Mahwah, NJ.

Who we want

• Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.

• Data translators. Highly effective communicators who can transform data findings into recommendations to compose reports and executive level presentations.

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

• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

• 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.

What you will do

In this highly visible role, the Staff Post Market Regulatory Specialist will be responsible for supporting post-market regulatory reporting activities, including but not limited to coordinating communications between Stryker and global regulatory agencies. You will also be responsible for participating in and leading high-level cross-functional projects and initiatives from planning through close-out, including the development and maintenance of dashboards and metrics to monitor the project status.

• Self-direct work under minimal supervision and demonstrate proficient leadership skills within the department.

• Support the management of high-level projects and initiatives, with responsibilities that include defining, managing and executing project charters and partnering with cross-functional groups to establish roles, responsibilities, and deliverables.

• Proficient at clearly identifying, analyzing, and understanding potential risks and problems and work with management to and assure the appropriate actions are taken

• Author and update divisional SOPs, recommend timely changes to ensure regulatory compliance, and lead process improvement initiatives to maximize efficiencies

• Coach and mentor less experienced staff. May also direct work of less experienced staff

• Operates with appreciable latitude for independent action or decision, and reviews progress with management

• Provide post-market adverse event data inputs to support the business and global regulatory agencies/notified bodies requests.

• Facilitate the management of additional information requests from global regulatory agencies and support the final responses

• Monitor impact of changing regulations and assist in the development of regulatory strategy to manage the changes

• Maintains product expertise related to specific assigned products to guide and coach others on team, including mechanical function of the product and clinical application

What you need

• A minimum of a bachelor’s degree (B.S. or B.A.) required, preferably in Science, Engineering or Regulatory.

• A minimum of 5 years overall business experience in a regulated manufacturing environment required, preferably in medical devices.

• Knowledgeable in post-market regulatory activities required.

• Previous experience with adverse event reporting is preferred.

• Experience developing and leading large-scale projects that require cross-functional collaboration with multiple teams throughout the business

• Well-developed intrapersonal skills with the ability to influence and gain respect and support from cross-functional teams, including the ability to effectively negotiate with internal and external business partners

• Demonstrates high level of professionalism and advanced organizational and planning skills

• Advanced written, verbal, and presentation skills

• Advanced PC skills (MS Outlook, Word, PowerPoint, Excel, Project) required

• Experience using analytic or business intelligence tools (Power Bi or Tableau), highly preferred.

• Demonstrates ability to comply with constantly changing regulatory and business requirements; reprioritizing work effectively

• Demonstrates the ability to rapidly build product knowledge and understanding of highly technical and scientific regulatory activities

• Demonstrated leadership in providing guidance, training, and mentoring to less experienced colleagues and cross-functional team members.

• Knowledgeable of US and International Medical Device Regulations and Standards including but not limited to: the Quality Systems Regulations CFR 21 Part 820, Medical Device Directives, FDA: CFR 21 Part 803 (MDR), CFR 21 Part 806 (Corrections and Removals), MEDDEV 2.12-1 (Guidelines on Medical Device Vigilance System), and ISO 13485 (International Organization for Standardization).

• Experience interacting directly with FDA and Global Regulatory Bodies.

• Analyze and resolve business and compliance issues using independent judgment.

• Communicate and network with personnel at all levels of the business to obtain relevant information.

Our benefits

Our total rewards offering varies by country but often includes 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.

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/