Senior Post Market Surveillance Specialist - Global Quality
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Do you have a solid understanding of regulatory requirements within the Post Marked Surveillance area (PMS)? Are you good at navigating within organisations, scouting for knowledge and data? And do you enjoy measuring -and transforming data it into clear Post Market Surveillance reports?
Right now, we are searching for a Post Market Surveillance (PMS) Specialist for the Complaint Management Team. The Complaint Management Team focuses on PMS reporting, customer support, analysing complaints and related data – including complaints with potential health and safe risk (PHSR). We are part of the global Quality Function area in Demant.
About the job
As our PMS Specialist you are responsible for the governance of the PMS area including compliance, reporting, and updating related processes (SOP), and templates. Your primary role is to collect and analyse data used in the PMS reporting. Secondarily you will manage investigation of PHSR complaints to ensure that they are properly documented and fit to be used in PMS reports.
As our PMS specialist, you will collaborate with other regulatory functions in the headquarters as well as regional stakeholders to collect inputs for PMS reports and to ensure cross functional alignment on procedures. Through good planning and stakeholder management competences you can ensure accurate and timely release of PMS reports.
For the PMS reports you will also use some of the data governed by the complaint management team. In collaboration with our data analysts your will establish best practices within the area and ensure that we stay up to date with respect to requirements for new data or reports.
Your key responsibilities
Qualifications & experience required
You have a good understanding of regulatory requirements gained from the Medical or MedTech business.
Establishing PMS report requires inputs from different teams, hence good stakeholder management and networking skills will be essential for you to establish accurate reports in due time.
Through experience you confidently analyse data and document conclusions.
Further, you:
We attempt to make a difference
Together with your enthusiastic and motivated colleagues, you will be part of a collaborative environment built on trust and openness, where you will find a strong motivation to do well. We are a growing international company, where everyone strives to ensure that customers find our products the most attractive on the market. You will become part of a work environment where flexible working conditions, knowledge-sharing and professional respect make it both interesting and meaningful to go to work.
Want to join us?
Kindly submit your application as soon as possible, as we are screening applications on a continuous basis. Deadline for the application is October 30., 2023. We only accept applications via our online recruitment system. If you have any questions, please contact Senior Manager of Complaint Management, Lars Jørgensen on +45 41 49 97 81.
We look forward to hearing from you.
#LI-NB1 #LI-HYBRID
Right now, we are searching for a Post Market Surveillance (PMS) Specialist for the Complaint Management Team. The Complaint Management Team focuses on PMS reporting, customer support, analysing complaints and related data – including complaints with potential health and safe risk (PHSR). We are part of the global Quality Function area in Demant.
About the job
As our PMS Specialist you are responsible for the governance of the PMS area including compliance, reporting, and updating related processes (SOP), and templates. Your primary role is to collect and analyse data used in the PMS reporting. Secondarily you will manage investigation of PHSR complaints to ensure that they are properly documented and fit to be used in PMS reports.
As our PMS specialist, you will collaborate with other regulatory functions in the headquarters as well as regional stakeholders to collect inputs for PMS reports and to ensure cross functional alignment on procedures. Through good planning and stakeholder management competences you can ensure accurate and timely release of PMS reports.
For the PMS reports you will also use some of the data governed by the complaint management team. In collaboration with our data analysts your will establish best practices within the area and ensure that we stay up to date with respect to requirements for new data or reports.
Your key responsibilities
- Continuously optimizing the SOP’s, instructions, and templates for the PMS area.
- Gather data across the company.
- Represent the PMS area during internal and external audits.
- Establish plans for PMS reporting.
- Prepare reports on Class 1 and Class 2 Products
- Safeguard schedules and deadlines for publishing plans and reports (e.g., in EUDAMED)
- Supervise investigation and documentation of PHSR complaints.
- Expand the PMS area if relevant and needed.
- Improve and automate data gathering and reporting methods.
- Collaborate with colleagues in the Data analyst function in developing new reports or establishing best practices.
Qualifications & experience required
You have a good understanding of regulatory requirements gained from the Medical or MedTech business.
Establishing PMS report requires inputs from different teams, hence good stakeholder management and networking skills will be essential for you to establish accurate reports in due time.
Through experience you confidently analyse data and document conclusions.
Further, you:
- Have compliance and regulation knowledge within ISO13485, Medical Device Regulation (MDR), FDA CFR 21 part 820 and MDSAP.
- Come from a similar position or have experience with the described job responsibilities from a QA or regulatory function.
- Understand the depth of the data you are collecting as you quickly acquire new knowledge about products and product structures.
- Have technical understanding and interest.
- Are a team person ready to join an engaged and friendly team.
We attempt to make a difference
Together with your enthusiastic and motivated colleagues, you will be part of a collaborative environment built on trust and openness, where you will find a strong motivation to do well. We are a growing international company, where everyone strives to ensure that customers find our products the most attractive on the market. You will become part of a work environment where flexible working conditions, knowledge-sharing and professional respect make it both interesting and meaningful to go to work.
Want to join us?
Kindly submit your application as soon as possible, as we are screening applications on a continuous basis. Deadline for the application is October 30., 2023. We only accept applications via our online recruitment system. If you have any questions, please contact Senior Manager of Complaint Management, Lars Jørgensen on +45 41 49 97 81.
We look forward to hearing from you.
#LI-NB1 #LI-HYBRID
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Smørum.
Jobbet er oprettet på vores service den 16.10.2023, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Øvrige
- Smørum
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