Regulatory Affairs Specialist

Description

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.

Communication/Contacts:

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.

Qualifications

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.

Travel Required

Occasional

Schedule

Schedule:Full time

Shift

Day

Duration

Over 12 Months

Job Function

Quality/Regulatory