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Regulatory Affairs Manager

Spring Professional — Neuchatel
21.11.2019 | Employé | 100%

Regulatory Affairs Manager

Responsibilities
  • Generate and/or submit regulatory filings/registrations for Europe including: update and/or prepare documents such as technical files, design dossiers and/or other documentation as required for regulatory submissions; ensure high-quality filings/registrations are submitted timely to regulatory bodies; and helps to update and/or create quality system procedures (SQP/SOP's) as required.
  • Manage regulatory activities which include coordinating product changes, regulatory requirements and submission schedules to assure timely regulatory approvals by effectively working with: internal functional departments including Customer Service, Sales (i.e. in-country managers), Technical Services, Marketing, Engineering, Quality Assurance/Compliance and Legal; and external parties including regulatory bodies such as notified bodies, distributors and consultants.
  • Provide regulatory leadership including: maintain current knowledge on regulatory requirements for Europe; provide regulatory guidance to internal functional departments; and able to function independently in daily activities with minimal supervision and able to keep management apprise of regulatory activities
  • Perform other duties or special projects as assigned
Profile
Minimum Qualifications:
  • Regulatory and technical abilities:
  • Must know regulatory submission requirements per the Medical Devices Directive (MDD) for Class I/IIa/IIb and have experience in quality systems per ISO 13485
  • Five or more years of work experience in a medical device Class II or III environment with three or more years in a role for regulatory affairs, product development (R&D), quality engineering or product safety
  • Must be able to think critically which includes analytical abilities such as interpret regulations and/or standards, apply them to product changes and determine resulting course of actions
Project management abilities:
  • Excellent prioritizing, organizational, and interpersonal skills
  • Ability to work in a fast-paced environment, with multiple tasks/projects
  • Ability to work in a cross-functional, project team environment
  • Excellent documentation skills including record maintenance/ tracking and understanding of document traceability
  • A detail-oriented individual, with a "can do" attitude, and the ability to work in a team environment, as well as individually (with minimal supervision)
General abilities:
  • Self-motivated and disciplined
  • Demonstrated ability to work in a matrix environment with non-local and local leadership
  • Ability to work across many time zones and manage flexible, non-traditional working hours as required to meet goals
  • Excellent English verbal and written communication skills
  • Detail-oriented
  • Computer proficiency with MS Office (Word/Excel/Powerpoint/Outlook)
Preferred Qualifications:
  • Experience in monitor systems, hospital-based products, software or electronic device products
  • Experience with the product safety testing process such as electrical safety, EMC and wireless testing
  • Experience interacting with regulatory bodies, such as the Notified Body
  • Knowledge of harmonized standards, such as IEC/ISO standards
  • Knowledge of regulatory requirements of countries located in the African region
À propos de Spring Professional
Booster votre carrière, décrocher un emploi qui vous motive ou trouver une nouvelle opportunité pour vous épanouir dans votre vie professionnelle. Autant d'objectifs auxquels nous croyons et pour lesquels nous vous conseillons jour après jour. Spring Professional est une entreprise de The Adecco Group, spécialisée dans le placement fixe et temporaire de professionnels qualifiés.

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Merci de préciser la référence JN -112019-298165.

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