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Principal Regulatory Affairs Specialist EMEAI (m/f/d) - Remote

United Kingdom | Belgium | Germany | Poland | Italy | France | Sweden | Spain | Remote

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Responsibilities

Location Buckinghamshire, GB Job ID JR-023487

Purpose of the main job

PerkinElmer is a global technology company focused on improving the health and safety of people and the environment.   The Principal Regulatory Affairs Specialist will support our business in expanding market clearance in emerging markets primarily in the EMEAI region.  He/she will support regulatory and commercial initiatives providing guidance on regulatory requirements and global regulatory strategies. 

Main responsibilities

  • Develop strategic regulatory plans and work with regional regulatory and commercial leaders to establish timelines
  • Participation on cross functional project teams to provide strategic guidance to meet  regulatory and business requirements
  • Support the regional regulatory teams in the preparation and timely completion of technical file submissions for in vitro diagnostic devices (assays, instruments, software) to meet project and business needs
  • Support regional regulatory teams and/or in-country dealers/representatives with regulatory registrations of products
  • Maintain up-to-date knowledge of  IVD regulations and applicable guidance, monitor development of regulations and communicate impact to regulatory and business leaders
  • Support importation / exportation process as required
  • Support classification, labelling, and registration process as required
  • Other duties as assigned

REQUIRED COMPETENCE

Education

  • Bachelor’s Degree in life science related field (Medical Technology, Clinical Chemistry, Biology or equivalent experience

Required work experience related to position

  • Minimum of 5 years’ experience in a Regulatory role
  • Excellent understanding of European regulations and guidance documents required
  • Knowledge of the Regulatory Scheme in Emerging territories eg Africa, Russia, Middle East
  • Previous experience supporting international registrations (CE marking, US 510(k) submissions required
  • Regulatory Affairs Certification or equivalent qualification preferred
  • Limited travel (up to 25% of the time, or as circumstances dictate)
  • Excellent interpersonal, verbal and written communication skills (in English)
  • Excellent time management, organizational, negotiation, and problem-solving skills
  • Ability to work independently and in a matrixed organizational structure, developing strong relationships with peers and levels of management

#LI-EMEA

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PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.

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“PerkinElmer has empowered and provided me the opportunity to learn and grow with the company. Every success is celebrated at PerkinElmer. I contribute every success to my supportive mentors and my team, the best that I have got in my entire corporate years. The sense of belongingness and respect for each other gave me a deeper meaning of what a family truly means. At PerkinElmer, I have found my family.”

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