Post Market Surveillance Department Manager

Job Description

Agilent inspires 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. .

One of our missions at Agilent is to help our customers around the world fight cancer and other life-threatening diseases. By providing our customers with the best solutions to ensure accurate and early diagnosis, we improve patient treatment and enhance survival rates.

Organizational Structure

Agilent has approximately 17,000 employees spread across Europe, the Americas and Asia Pacific. The global footprint includes sales offices, logistics centers, business facilities, and manufacturing sites in three major geographies. Agilent-s worldwide capabilities enable them to deliver high-quality solutions to their valued customers in 110 countries.

Agilent-s footprint

There are 3 Business Units (called Groups in Agilent):

Agilent CrossLab Group (ACG)

Diagnostics - Genomics Group (DGG)

Life Sciences and Applied Markets Group (LSAM)

Diagnostics - Genomics Group (DGG) has 6 Divisions:

Nucleic Acid Solution Division (NASD)

Biomolecular Analysis Division (BAD)

Pathology Division (PT)

Reagent Partnership Division (RP)

Companion Diagnostics Division (CDx)

Genomics Division

Manufacturing sites are not always linked directly to each division, as some sites manufacture products that cover 2 or more divisions, e.g. Glostrup site in Denmark is manufacturing primarily for PT but it also manufactures for RP and CDx. Glostrups- sister-site is based in California, and it manufactures for CDx but also for RP and PT. The whole DGG is dedicated to in-vitro diagnostics (IVD) for oncology.

The position

The position is within DGG, Pathology/RP Division. Quality organization in PT/RP in Agilent Technologies Denmark is in a process of transformation towards a strong robust function that will support the business and assure compliance at all times.

Post Market Surveillance (PMS) department has recently become a part of the Quality organization, and we are looking for a strong profile that will lead this department. The department is managing all PMS activities according to the requirements defined in In Vitro Diagnostic medical devices Regulation (IVDR) (EU) 2017/746. This includes among others preparation and execution of Post-Market Surveillance Plan (PMSP), Post-Market Performance Follow-up Plan (PMPFP), Post Market Surveillance Report (PMSR), Periodic Safety Update Report (PSUR), and Post Market Performance Follow-up Report (PMPFR).

The department comprises three (3) specialist, one (1) consultant, and one (1) student assistant. You will be based in Glostrup, Denmark and will be reporting to Site Quality Head, Pathology/RP Division, Glostrup Site.

In your role you will ensure:

Post market surveillance is proportionate to the risk class and the type of the device in question.

Adequacy of post market surveillance system in order to minimize risks and prevent incidents, which might result in faulty risk evaluations and/or field safety corrective actions.

The risk management system is carefully aligned with and reflected in the performance evaluation process for the device, including the post-market performance follow-up. The risk management and performance evaluation processes should be inter-dependent and should be regularly updated.

Post market surveillance is consistently performed, and completion and reporting of PMSR / PSUR / PMPFR is performed in a timely, consistent, and compliant manner.

You will together with your team identify among others:

Updates to design and manufacturing information, the Instructions for Use (IFU) and the labelling.

Updates to the performance evaluation.

Updates for the Summary of Safety and Performance (SSP).

Needs for preventive, corrective or field safety corrective actions.

Options to improve the usability, performance, and safety of the device.

Any relevant information to contribute to the PMS

Reported trends.

You will have close cross-functional collaboration with among others Quality, Research - Development (R-D), Regulatory Affairs (RA) and Manufacturing.

Qualifications

Degree within Pharmacy, Medical Engineering, Molecular Biology or other similar natural sciences

+7 years of work experience in the medical device or pharmaceutical industry

+7 years supervisory experience (managing direct reports), including hiring, training, coaching and performance management activities

Preferably experience working with In Vitro Diagnostic and/or Medical Devices

Strong knowledge and understanding of standards and regulations: ISO 14971:2019, Regulation (EU) 2017/746, FDA CFR 21 Part 820, ISO 13485

Strong analytical skills with focus on finding the right solutions in compliance with the regulations.

High professional level in written and spoken English and preferably also in Danish

Personal skills

Data oriented with risk-based approach

LEAN mindset

Excellent communicating skills

Thrive working cross-functionally with people at all levels of the organization

Flexible, systematic, and engaged team player

Robust with a sense of urgency combined with a good sense of humor

Self-motivated with a high level of engagement

Your team-s expectations to you:

You have an open-door policy

You like working with people and you are interested to understand and value the skills and attitudes of each member of your team.

You are always happy to make your technical competences available to your team, to facilitate and improve the daily work in the department

You are prone to build relationships within the company at many levels, to enforce the collaborative role of stakeholders in PMS activities.

You are able to create initiative, to motivate your team and enforce its technical training in PMS, for a continuous improvement of PMS processes.

You strive to understand the differences in each team members preferences, motivations and foster professional development for each individual member of the team.

You understand how to delegate tasks and responsibilities to the team members, which encourage professional growth and success.

You have a willingness to listen to your team members and communicate clearly about what is expected.

In addition to all of the above we expect you to have a high drive and are focused on creating results (goal oriented). You have a proven track record of a strong leadership and communication skills. You are good at setting goals and direction. You have a good business understanding and are able to drive change through clear communication, motivation, coaching, and working with other stakeholders in cross functional groups. This is a position in an international and dynamic working place with exciting challenges and opportunities.

Agilent values and culture

You will become part of a company with culture based on to the values: innovation, trust, respect, collaboration, and uncompromising integrity. Added to these traits are speed, focus and accountability to meet customer needs and build a culture of performance that draws on the full range of people-s skills and aspirations.

Agilent Technologies is an equal opportunity employer and value diversity at our company. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, disability status or any other protected categories under all applicable laws.

Practical information

Start: We will be interviewing on-going, and the position will be filled as soon as the right candidate has been identified

Salary: According to qualifications and Agilent defined salary range

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

No End Date

Job Function

Quality/Regulatory

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