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Regulatory Affair Specialist (m/f) in Pusignan bei Stryker Corporation

Datum der Veröffentlichung: 3/21/2019



Your main responsibilities :

  • Develop, implement and maintain compliant, harmonised, best practice market clearance / registration processes in Stryker France.
  • Provide maturity and significant RA experience and expertise to the EMEA regulatory team to accelerate market access.
  • Ensure timely market access and regulatory compliance in Stryker France and build collaborative relationships with French regulatory bodies.
  • Leads the execution and delivery of the French registration plan and reviews product documentation in accordance with French regulatory requirements.  
  • File, maintain and organise local registration submissions and maintain regulatory flags in local ERP system.
  • Primary contact with French Competent Authority on market clearance activities, ensuring ongoing market access in line with business strategy.
  • Supports the execution of submission strategies and registration planning in France in collaboration with RA leadership.
  • Reviews product change notifications issued by international manufacturing sites, evaluates re-notification requirements and communicates to EMEA regulatory team.
  • Maintain active participation in product lifecycle management planning and associated regulatory  execution.
  • Build, implement and maintain effective local product registration processes.
  • Analyse and monitor registration activity for all franchises on a periodic basis to ensure performance is in line with objectives and communicate performance to RA leadership.
  • Provide regulatory guidance and training to EMEA RAQA colleagues, new starters and Design Divisions as a subject matter expert on French regulations.
  • Monitor regulatory changes across France and escalate to RA leadership as necessary.
  • Support the training of international Design Divisions in understanding registration requirements in France and design inputs for new product development.
  • Provide support to the local French RAQA team and EMEA Regulatory team on various activities as appropriate.
  • Support Corporate / International projects as required.

What we are looking for/Your Profile :

  • Maturity, experience and knowledge to represent RA to internal and external customers.
  • Degree graduate (Science / Engineering / Business fields)
  • Advanced qualifications in Regulatory Affairs preferred (e.g. RAC)
  • Minimum of 3 years in an RAQA role with a proven successful track record.
  • Sound knowledge of European medical device regulatory frameworks (MDD and MDR).
  • High level communication skills.
  • Experience working in a matrix environment in a global company.
  • Well established communications with key stakeholders.
  • Proven and measurable track record of medical device registration execution within France and / or other European markets.
  • Capable of leading complex projects autonomously (problem solving oriented). 
  • Work to strict deadlines and under pressure. 
  • Fluent in French and English
  • Project management skills
  • Ability to communicate effectively with RAQA and Commercial management teams
  • Strategic thinker
  • Strong communication and team working skills
  • Proactive mindset
  • Analytical skills
  • Ability to prioritise and organise own workload
  • Ability to analyse data and statistics and present to varied audiences
  • Embrace working with different geographical cultures
  • Customer orientated
  • Leadership attitude
  • Creative but realistic
  • Accurate and conscientious

Work From Home: No

Travel Percentage: Up to 25%

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