Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Stryker

Elstree, United Kingdom

Job Description

Your key responsibilities

  • 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.

What are we looking for?

  • BS in Engineering, Science, or related degree; or MS in Regulatory Science;
  • Typically a minimum of 3 years experience;
  • MS or RAC(s) preferred;
  • 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;
  • 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.

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© EuroJobsites 2018

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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