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Welcome to SVA’s jobs portal, your one-stop shop for finding the most up to date source of employment opportunities. We have partnered with the National Labor Exchange to provide you this information. You may be looking for part-time employment to supplement your income while you are in school. You might be looking for an internship to add experience to your resume. And you may be completing your training ready to start a new career. This site has all of those types of jobs.

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Stryker Senior 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.

Key Areas of Responsibility:

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

  • 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

  • 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

  • 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

Education / Work Experience:

  • BS in Engineering, Science, or related degree; or MS in Regulatory Science

  • Typically a minimum of 2 years’ experience

  • MS or RAC(s) preferred

Knowledge / Competencies:

  • Project management, writing, coordination, and execution of regulatory items

  • Perform technical and scientific regulatory activities

  • Usually works with minimum supervision, conferring with superior on unusual matters

  • Assignments are broad in nature, requiring originality and ingenuity

  • Has some latitude for unreviewed action or decision

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.

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