Senior Regulatory Specialist (m/f/d) – IVD

MiE GmbH; Waldbronn; Hybrid; EUR 60.000 - 100.000; Vollzeit

Zusammenfassung

An established industry player is seeking a Senior Regulatory Specialist to join their Global Regulatory Affairs team. In this pivotal role, you will support new product introduction projects and develop regulatory strategies to facilitate the global market entry of IVD products. Your expertise will ensure compliance with international regulations, and you'll collaborate with various departments to address regulatory challenges. This position offers a hybrid work model based in Waldbronn, Germany, or anywhere in Europe. Join a dynamic team committed to innovation and quality in the life sciences sector, and enjoy a range of benefits including career development opportunities and a supportive work environment.

Leistungen

Yearly company bonus

Private health care

Pension scheme

Discounted stock purchase plan

Medical & life insurance

Career development opportunities

Work-Life-Balance

Permanent contract

Qualifikationen

• Several years of relevant experience in a regulated environment.
• Knowledge of international registrations and compliance standards.

Aufgaben

• Support new product introduction projects and develop regulatory strategies.
• Coordinate and track international submissions and licensing requirements.

Kenntnisse

Regulatory Affairs

Quality Assurance

Project Management

Communication Skills

Team Collaboration

Ausbildung

Bachelor’s degree in Regulatory Affairs

Bachelor’s degree in Quality Assurance

Bachelor’s degree in Engineering

Bachelor’s degree in Science-related discipline

Tools

SAP

Jobbeschreibung

Agilent encourages and supports discoveries that advance the quality of life. We provide life science, diagnostic, and applied market laboratories worldwide with instruments, services, consumables, applications, and expertise. Agilent enables customers to gain the answers and insights they seek — so they can do what they do best: improve the world around us.

We are searching for a highly motivated Senior Regulatory Specialist (m/f/d) to be part of our Global Regulatory Affairs team where you will play a key role in supporting new product introduction projects and developing regulatory strategies to help bring products to the global market, coordinating and tracking international submissions, product change notifications, product release and licensing requirements, and registration of IVD products for Agilent’s IVD products.

Senior Regulatory Specialist (m/f/d) – IVD

The position helps to ensure products are received, licensed, and delivered by Agilent are performed in accordance with global regulatory and quality standards and regulations. As a member of the Agilent Global Regulatory Team, you will provide support to business teams for IVD registrations internationally such as the following:

• Prepares document packages for regulatory submissions and listings to ensure alignment and compliance with local and regional registration requirements and company policies.
• Compile materials required in submissions, license renewal and annual registrations. Maintains export licenses within SAP software for IVD licenses along with addressing global trade holds.
• Develops and implements programs and processes to ensure that company products are safe, legal, and meet customer expectations for compliance with national/regional/global regulations.
• Problem solve and raise regulatory and compliance issues to senior management as necessary.
• Monitor regulations and changes in the regulatory environment and participate on discussions related to regulation changes (Trade Associations) and anticipate, assess, and communicate changes to keep internal stakeholders updated on potential risks and opportunities that could impact ongoing and future projects.
• Leads regulatory projects requiring coordination with other functions, such as Legal, Marketing and Project Management along with Agilent distributor partners.
• Support regulatory impact assessments for change controls for changes that are currently registered.
• Coordinate preparation of product documentation needed for obtaining regulatory permits, licenses, and registrations.
• Consult with regulatory agencies as required to obtain interpretation and guidance on regulations as they apply to Agilent products.
• Communicate with Agilent Channel Partners regarding registrations and change assessments.

This position is preferably based in our Waldbronn office in Germany (hybrid model), but can also be based anywhere in Europe where Agilent has an entity.

Qualifications:

• Bachelor’s degree in Regulatory Affairs, Quality Assurance, engineering, or other science-related discipline
• Several years of relevant experience in regulated environment
• Knowledge and experience with international registrations
• Demonstrated teamwork skills and ability to lead, collaborate and work effectively in teams across different businesses, functions, and geographies
• Quality Management System (QMS) experience for medical devices industry
• Proficient written/spoken communication in English.
• Experience working with global resources across several departments or functions

Preferred Qualifications

• Excellent communication, strong project management and presentation skills
• Working knowledge of design controls and knowledge of applicable standards (ISO 13485 and 14791)
• Experience working with regulated products; knowledge of ISO Quality standards and IVD regulations

We offer:

• Agilent offers core global benefits to all staff – but in addition to this, the business offers a yearly company bonus, private health care, pension scheme, discounted stock purchase plan, medical & life insurance (these may vary from country to country)
• An opportunity for you to grow within a world-class company to develop your skills with career development opportunities in an international company
• The diversity of cultural and individual perspectives held by our employees and their commitment to inclusion
• An independent job among good colleagues, in a growth orientated conglomerate. You will become part of a caring and fast paced environment, built on integrity, information, and trust.
• Exciting projects in a dynamic collaborative team grounded on an agile culture
• Work-Life-Balance is encouraged
• Permanent contract in a fast-growing global company

We look forward to receiving your application in English.