Regulatory Product Surveillance Specialist, GN Hearing (ReSound)

Join us at GN Hearing – part of the GN Group – we bring people closer

At GN we design and manufacture world-leading intelligent audio, video, and gaming communication solutions. We have consumer, professional and medical-grade products and expertise, all under one roof.

Inspired by people and driven by our passion for innovation, we leverage technologies to deliver unique user experiences that bring people closer through the power of sound.

GN's market leading solutions are marketed under brands such as ReSound, Beltone, Interton, SteelSeries, Jabra, BlueParrott and FalCom in more than 100 countries. GN Group employs over 7000 people and is listed on Nasdaq Copenhagen (GN.CO).

Welcome to our Regulatory Product Surveillance team

The surveillance of our product quality and market feedback is important for our business. The team is small and friendly team, liked and known for our ability to bring important insights into our product quality. We believe in developing as people, allowing the flexibility for work life balance, and creating a nice and engaging workspace.

As our new Regulatory Product Surveillance Specialist, you will be based at our global HQ located in Ballerup, Denmark and report to Akanksha Roy, Regulatory Product Surveillance Manager.

What you will be doing

Your primary focus will be to ensure that our products comply with current and future global medical device regulations, including the EU Medical Device Regulation (MDR), adhering to applicable deadlines. From a clinical perspective you will be assisted by your manager and experienced colleagues in this area.

Applying your technical expertise, you will have a broad range of responsibilities, such as:

• Lead and facilitate PMS activities in accordance with relevant global regulations, to support our products regarding safety and performance.

• Establish communication with a range of stakeholders at HQ and at affiliates around the globe, such as R&D, Quality, Customer Support, Product Management and Global Sales. 

• Contribute to continuous improvement of PMS processes and procedures and conduct training as appropriate.

• Collect and interpret post market surveillance (PMS) data from multiple stakeholders, including writing PMS plans and reports, and Periodic Safety Update Reports.

• Interact with authorities to fulfill the regulatory requirements related to PMS, Vigilance, and Trend Reporting (e.g. reporting of serious incidents and Field Safety Corrective Actions).

• Support the department and organization during internal and external audits.

• Handle safety complaints and associated vigilance reporting and procedures, and any necessary future updates.

Sounds good so far? Here’s what you’ll need to succeed and create results

Overall, we anticipate that you to be interested in quality, vigilance and data. We believe that the following will increase your chances of success in the role:

• Master’s degree within a technical field

• Post market experience and/or regulatory experience

• Experience with quality systems in the Medical Device Industry

• Experience from working with Safety Complaints or Vigilance

• Experience with scientific writing and audits/inspections

• Knowledge of Medical Devices and related standards, e.g. MDR, ISO 13485 and 21CFR Part 11

• Experience of Trend Reporting, as defined within Article 88 of the EU MDR. 

• Excellent planning, cooperation, and communication skills.

• Ability to handle confidential information.

• Ability to adapt, cope with setbacks, and be resilient.

Nice to have but not required

• MDR certification

• Power BI and/or QLINK software experience for trend reporting

• Project management

Fluent written and spoken English skills

As an international organization with colleagues in over 50 different countries, our official company language is English. It’s essential that you can communicate effortlessly with your colleagues, no matter where they are.

The GN culture

GN’s values listen, challenge, and transform form our culture. We greet every day with energy, engagement, and enthusiasm, bringing our best selves and approach problem-solving and challenges with a ‘glass half full’ attitude.

We’re independent, but we also know when two heads are better than one. Our leaders are supportive, our teams are tight-knit, and we believe in the power of collaboration across every level of our organization.

While making a big difference for all our customers, we also believe in creating a fantastic and flexible work environment. We want everyone to contribute with their ideas and encourage everyone to contribute with improvements that can benefit our products or the way we do things. We believe this is stimulating for our organization and for all team members.

Our workplace offers plenty of different benefits and flexibility to keep us happy and healthy and allow us to focus on what matters to us in and outside of work. We hope you are curious to explore and engage in the recruitment process with us.

Think you’ve got what it takes? Apply now

To apply, use the ‘APPLY’ link no later than June 19th, 2023. Applications are assessed on a continuous basis, so don’t wait to send yours.

Quick apply
 

You are welcome to use our Quick Apply functionality, where you only submit your CV. We only ask that your CV is up-to-date quick, and easy.

If you want to know more about this specific position, you are welcome to contact Regulatory Product Surveillance Manager, Akanksha Roy, tel. +45 27645823.

We hope you will join us on this journey and good luck with your application.

#LI-ReSound