Senior Regulatory Affairs/Post Market Specialist, EMEA in Maastricht at Stryker Corporation

掲載日付: 11/30/2019

求人のタイプ

仕事内容

Stryker Medical (Location: Maastricht, The Netherlands)

Who we want:

  • Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
  • 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 regulatory requirements squarely in focus, people who deliver safe and robust solutions.

What you will do:

The Senior Regulatory Affairs/Post Market Surveillance Specialist works to bring medical devices, medicinal products, cosmetics and biocides to market and ensures ongoing compliance for our Sage Products portfolio in EMEA.

  • Participates on cross-functional teams, collaborates with internal and external business partners to support product expansions globally.
  • Establishes and maintains a good working relationship with US-based design/manufacturing colleagues and regional RA peers to gain positive & timely support for document preparation.
  • Determines regulatory requirements, develops regulatory submission strategy and authors regulatory submission documents for product launches and line expansions globally.
  • Interacts with regulatory agencies/notified bodies, reviews labeling and marketing materials, and evaluates proposed device changes for registration impact
  • Handles necessary complaint handling process activities for global markets
  • Determines reportability to the appropriate authority for events that either contributed or could have contributed to adverse events
  • Submits initial and follow-up reports to regulatory Agencies as needed
  • Facilitates training on product complaint and adverse event reporting requirements
  • Supports Post Market Surveillance for EU Medical Devices
  • Support tender operations by timely supply of accurate regulatory documents
  • Establishes relationships with local medical device industry groups and works with industry peers to lobby the Competent Authorities in matters of regulatory issues and to influence local policies

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
  • 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, pre-clinical, and clinical data to meet applicable regulations
  • Assesses the acceptability of quality, pre-clinical, and clinical document for submission filing to comply with applicable regulations
  • Evaluates proposed pre-clinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions
  • 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

What you need

  • Bachelor’s degree required with Engineering, Biological Sciences or relevant equivalent experience;
  • 5+ years of Regulatory Affairs experience within medical device, biologics and/or pharmaceutical industries
  • Understanding of regulatory landscape in EU/EEMEA markets
  • Ability to understand and explain detailed regulatory compliance issues
  • Ability to comply with constantly changing regulatory procedures and prioritize work effectively
  • Ability to analyze and resolve non-routine regulatory issues using independent judgement
  • Demonstrated analytical, writing and organizational skills
  • Demonstrated interpersonal, written and oral communication skills
  • Fluent in English

You might also have

  • Working knowledge of the EU Medical Device Regulation
  • Previous experience with EU Regulatory System for Medicines
  • Previous experience with EU Cosmetic Products Regulation

Travel: 20-30% of the time

Work From Home: Not available

Travel Percentage: 30%

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