Senior Staff Regulatory Affairs Specialist (Remote)

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.

• 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.

• Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.

What you will do

As a Senior Staff Regulatory Affairs Specialist, you will support Stryker’s Upper Extremity portfolio by partnering with new product development teams to bring orthopedic medical devices to US and OUS markets by developing robust regulatory strategy, authoring submissions and negotiating product clearances and / or approvals for target markets (e.g. US, EU). You will support the product lifecycle by assessing design changes, manufacturing changes and labeling changes made to marketed devices. You will support cross-functional teams by advising teams on applicable global regulatory requirements, standards requirements and assessing changes to marketed devices. You will ensure regulatory compliance by completing thorough assessments, documenting robust regulatory strategies and filing the appropriate submissions to the required markets (e.g. FDA, Notified Body) for clearances and / or approvals.

• 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 to providing internal advice 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

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

• Evaluates proposed products for regulatory classification and jurisdiction

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

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

• Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes

• Negotiates with regulatory authorities throughout the product lifecycle

• Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation

• Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance

• Assists other departments in the development of SOPs to ensure regulatory compliance

• Provides regulatory input and technical guidance on global regulatory requirements to product development teams

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

• Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations

• Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions

• Identifies, monitors, and submits applicable reports or notifications to regulatory authorities during the clinical research process

• 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 submissions according to applicable regulatory requirements and guidelines

• Monitors the progress of the regulatory authority review process through appropriate communications with the agency

• Communicates 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 for interactions with regulatory authorities including panel meetings and advisory committees

What you need

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

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

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

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

• General understanding of product development process and design control required.

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

• Thorough understanding of FDA and international medical device regulations.

• Previous experience with US FDA submissions (i.e. 510(k) or PMA) and EU Notified Body, including associated submissions required.

• Experience interacting with regulatory agencies required.

• 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.

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