Regulatory Affairs Manager
Profile Minimum Qualifications:
- 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
Project management abilities:
- 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
- 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)
- 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
- Computer proficiency with MS Office (Word/Excel/Powerpoint/Outlook)
À propos de Spring Professional
- 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
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Merci de préciser la référence JN -112019-298165.