Staff Regulatory Affairs Specialist (Remote)

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, Stryker is encouraging US employees as well as all new US employees joining our company to be fully vaccinated against COVID-19. Today or in the future, vaccination may be a requirement based on the essential functions of the specific role or applicable regulations. Please refer to our COVID-19 Vaccination Requirements FAQs page for current vaccination and/or reasonable accommodation requirements and timelines.

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 Staff Regulatory Specialist to join our Medical Division to be based in Portage, MI or remotely within any state located within the Central Standard Time Zone or the Eastern Standard Time Zone.

Who we want

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

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

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

What you will do

As the Staff Regulatory Affairs Specialist, you will support Stryker Medical’s Hospital Bed and Support Surface portfolios for our global market. You will be responsible for enabling global product sales by registering products in accordance with health authority requirements, maintaining registration status throughout product lifecycles, advocating for relevant functions of the Quality Management System, and analyzing regulatory intelligence. You will be a key partner in ensuring continued product compliance through EU MDR and UK CA initiatives. You will liaise with internal and external customers and establish strong relationships with global Health Authorities and Stryker personnel located in international countries. You will translate complex engineering or scientific principles into approachable content while educating others on Stryker products and processes.

• Assess regulatory intelligence to assist in the development of local, regional, and global regulatory strategies.

• Evaluate the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance.

• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions.

• Assist in the development of regulatory strategy and updates strategy based upon regulatory changes.

• Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities.

• Provide regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization.

• Negotiate with regulatory authorities throughout the product lifecycle.

• Advise stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations.

• Prepare and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines.

• Communicate and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools.

• Work with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees.

What you need

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

• A minimum of 5 plus years of experience in a regulated industry required; preferably with medical devices.

• A minimum of 2 years of Regulatory Affairs experience required.

• RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.

• General understanding of product development process and design control.

• Thorough understanding of EU and international medical device regulations required.

• Previous experience drafting regulatory submissions preferred.

• Experience interacting with Notified Bodies and regulatory agencies preferred.

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

• 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.

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