Reporting to the Glostrup site Regulatory Manager, the RA Specialist is expected to provide regulatory support for current development, manufacturing, and partner programs to obtain regulatory clearance of designated products/projects.
Moreover, the position is to develop appropriate submissions and regulatory documents for product submissions, annual reports, and other relevant regulatory documents to ensure that product regulatory decisions and rationale inclusive of instrument hardware, software and user interface risks and interactions meet global requirements.
Finally, the RA Specialist is to ensure that product regulatory risks are mitigated with developed regulatory plans by supporting product investigations and field actions on critical product issues, as required.
Job Responsibilities Preparing and developing effective and targeted document packages for international regulatory submissions (new and mature products). Building and maintaining a strong collaborative platform with internal and external partners eventually leading to regulatory clearance. Developing appropriate submissions and regulatory documents for global coordination of product submissions, annual reports, and other relevant regulatory documents. Works on company regulatory assignments with clearly defined objectives Review product labeling and marketing materials for compliance with approved claims and regulations. Assessment of design/labeling/ manufacturing changes Interpretation/assessment of new/changed regulatory requirements Development of systems and/or technical procedures in own area Basic understanding of design controls and applicable standards Conformity assessment (EU, AU, CA) and CE-marking Solves straight-forward issues, challenges, and problems within area of specialization
In the position you will refer to the Manager, Regulatory Affairs - Pathology & Reagent Partnerships.
Internal Coordinates regulatory project activities with project managers, colleagues, and management. Ensures seamless coordination with internal and external partners to obtain regulatory clearance and/or approval of designated products/projects in line with regulatory strategies and rationales.
External: Represents company in external bodies dealing with standards and/or product regulations at the national/regional/global level. Responds to customers and/or authorities requests/inquiries dealing with regulations and product compliance.
Education: Relevant Bachelors or Master’s Degree or equivalent University Degree.
Experience: 2+ years of relevant experience.
See what it's like to work at Agilent Technologies and what we offer you:
Agilent offers a competitive compensation and benefits package, as well as core global benefits to all staff - but in addition to these, the Danish business offers: Agilent Result Bonus Stock Purchase Plan Employee Assistance Program Accident Insurance Health Insurance Life/Death Insurance Critical illness/ disability Insurance Pension Extra vacation days (feriefridage) Fitness Art club Physiotherapist Holiday cottages Canteen
Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.
Over 12 Months