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Job Information
Stryker Senior Staff Regulatory Affairs Specialist in Cork, Ireland
We are excited to be named one of the World’s Best Workplaces by Fortune Magazine!
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.
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 Staff Regulatory Affairs Specialist to support our ENT Division. The role is based in Cork , Ireland.
Who we want:
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.
Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
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.
What you will do:
Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies
Participates in advocacy activities of a more advanced technical and/or tactical or strategic 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
Identifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)
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
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
Provides knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships
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:
BS in Engineering, Science, or related or MS in Regulatory Science
Typically a minimum of 7 years experience
RAC(s) preferred
Demonstrate knowledge and skills in areas such as regulatory pathways; risk-benefit analysis; communication and collaboration internally and externally; submission, registration, obtaining approval, documentation and compliance .
Operates with appreciable latitude for unreviewed action or decision
Seeks out diverse ideas, opinion, and insights and applies them in the workplace
Connects and relates well with people who think and act differently than oneself
Embraces scrutiny and accepts feedback as opportunity to learn and improve
Chooses the best alternative to achieve desired outcome or effect, giving consideration to risks, tradeoffs, timing, and available resources
Navigates the dynamics, alliances, and competing requirements of the organization or business
Willingly accepts challenging assignments and new career opportunities that stretch and build capabilities
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
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.