Staff Regulatory Affairs Specialist

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 our RA/QA team, that's exactly what you'll do! At Stryker, we provide our Regulatory Affairs teams the opportunity to learn new things, as well as growth opportunities. If you’re in working at one of the World’s Best Workplaces, apply today!

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 Regulatory Affairs Specialist to join our Sternal Plate and Cranial iD Division to be based in Portage, MI or anywhere in Central or Eastern time zones.

Who we want

• 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.

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

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

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

• 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.

What you will do

As a Senior Regulatory Affairs Specialist, you support new product development for both the US and OUS global regulatory release by contributing to the development and updating or regulatory strategy based upon regulatory changes. You support the product lifecycle through obsolescence by assessing changes made to the device post launch to determine regulatory impact of changes to the current clearance. You also ensure regulatory compliance by completing through assessments and the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies and other regulatory bodies. You are viewed as a regulatory team resource.

• Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies
• Participates in advocacy activities of a technical and/or tactical nature
• Evaluates the regulatory environment and contributes by providing internal advice to the regulatory groups, new product development and others within the organization throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance
• Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions
• Identifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, purchasing groups, etc.)
• Evaluates proposed products for regulatory classification and jurisdiction
• Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
• Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation including assisting other departments in ensuring their SOPs are compliant
• Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
• Advises stakeholders of the assessment of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations
• Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for appropriate regulatory pathways
• Provides regulatory information and guidance for proposed product claims/labeling
• Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims
• Prepares and submits electronic and paper regulatory pre-market and post-market submissions according to applicable regulatory requirements and guidelines
• Monitors the progress of the regulatory authority review process through appropriate communications with the agency
• Communicates, negotiates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools
• Works with cross-functional teams on interactions with regulatory authorities including panel meetings and advisory committees

What you need

Minimum qualifications:

• Bachelor’s degree in Engineering, Science, Regulatory or equivalent focus
• Minimum 5 years professional experience with at least 3 years direct regulatory affairs experience within the medical device or pharmaceutical industry

Preferred Qualifications

• PMA
• MS or RAC(s) preferred
• Experience with medical devices especially Class II and Class III devices
• Experience authoring regulatory submissions for product approval and interaction with regulatory agencies

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