Stryker Regulatory Affairs Integration and EU MDR Specialist in Sioux Falls, South Dakota
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 Regulatory Affairs Lead Integration and EU MDR Specialist to join our Medical division.
Who we want
Strategic. Creates alternative ways to proceed. Faced with any given scenario, can quickly spot the relevant patterns and 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.
Communicators. Articulates well and expresses ideas effectively.
Learners. Great desire to learn and looks to continuously improve.
Teammates . Supports, encourages, and inspires others.
What you need
As a Senior Staff Regulatory Affairs Specialist, you will serve as a Regulatory Affairs Subject Matter Expert and Process Owner for two primary areas: Integration of acquired products, services and businesses into Stryker's regulatory processes and leads the division as the subject matter expert to implement the new EU MDR regulation. You will have leadership over our division-wide program to implement the new EU MDR regulation for the Medical division, interfacing with Corporate and site SMEs as well as RAQA leadership throughout the division. Involvement in exciting new business development activities, representing regulatory affairs as an SME in due diligence and integration.
For integration, you will perform the assessment and gap closure requirements of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company as well as internal audits and inspections, with a focus in the international regulatory landscape. You will work with acquired sites to ensure all materials required in submissions, license renewal and annual registrations are appropriately compiled and meet Stryker's standards. You will also recommend changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance along with monitor and improve tracking/control systems while keeping abreast of regulatory procedures and changes.
For EU MDR Divisional Process Owner, you will serve as the division-wide SME with deep knowledge of the EU MDR regulation. You will relate past regulatory requirements to current ones and help others close gaps; additionally, you should be able to interpret requirements into feasible, sustainable, business-oriented solutions. You will connect with cross-functional leaders to understand needs, concerns and the future product landscape and lead other SMEs at various sites within the Medical division to ensure an aligned, compliant interpretation of the EU MDR regulation. You will also need to understand site concerns and represent the Medical division's needs during Corporate or external forums.
Key responsibilities include:
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
Coordinates input, feedback, and represents their division's needs
Accountable for local process and training implementation including all Divisional business units and acquisitions in scope
Updates the GPO and/or PMO on divisional deliverables and progress
Ensures the global initiatives in their area are communicated and understood by divisional stakeholders
Serves as the voice for their division in the process area
Travels to hub and spoke meetings
Engages in meetings, surveys, information gathering and decisions
Delivers against agreed project deadlines
Communicates to leadership and stakeholders throughout levels at their division/site
What you need
Bachelors degree in Engineering, science or equivalent focus
7+ years experience in an FDA or highly regulated industry
Technical and management skills and engaged in regulatory strategy and operations
Demonstrated knowledge and skills in areas such as regulatory pathways; risk-benefit analysis; communication and collaboration internally and externally; submission, registration, obtaining approval, documentation, compliance, postmarketing surveillance/vigilance; and distribution
Ability to seek out diverse ideas, opinion, and insights and applies them in the workplace
Connect and relate well with people who think and act differently than oneself
Embrace scrutiny and accept feedback as opportunity to learn and improve
Choose the best alternative to achieve desired outcome or effect, giving consideration to risks, tradeoffs, timing, and available resources
Navigate the dynamics, alliances, and competing requirements of the organization or business
Willingly accepts challenging assignments and new career opportunities that stretch and build capabilities
Subject matter expert for the regulatory and Stryker-business requirements of their area of ownership
Effective communicator and consensus-builder
Proven ability to implement large-scale projects on a broad scale
You may also have
RAC or advanced degree (Masters in Regulatory Affairs)
Prior divisional or site experience
Work From Home: Remote
Travel Percentage: 20%
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.
Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com
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