RA Specialist – with Clinical interest
Ferrosan Medical Devices A/S
About Ferrosan Medical Devices A/S
Ferrosan Medical Devices A/S develops and produces a portfolio of hemostatic products to aid surgery minimizing bleeding challenges. Products are registered as medical devices (Class III) and are sold internationally in more than 100 countries in close collaboration with the main customer and innovation partner Ethicon, part of Johnson & Johnson. All main functions in the company are in Søborg, DK including production facilities, so everyone sits door to door with easy access to each other.
The company is growing and has a long-term strategy which involves several early innovation projects discovering the next generation hemostatic products.
We are looking for a RA Specialist to deliver strong regulatory strategies and targeted global filings to support our Class III medical devices and combination products within the field of surgical hemostasis. Being on a growth and innovation journey with more devices in the pipeline requires more RA employees and therefore we are expanding our team. The department consists of 7 RA professionals including 1 employee responsible for Post Marketing Surveillance (PMS). You will report to the RA Director.
As RA Specialist in Ferrosan Medical Devices, you will have the opportunity to impact the success of the company. The results of your performance will have a significant impact on critical business activities within both new product development/innovation activities and life cycle maintenance projects.
Depending on your interests and background you will also be able to develop your skills in the clinical area.
The position as a RA Specialist in Ferrosan Medical Devices is an important, exciting, and challenging role with a wide scope and many stakeholders. You will have a wide degree of cross-functional interaction with skilled and dedicated colleagues from Operations Support and Development, Supply Chain, QA/QC, New Business Development and Commercial Development You will also enjoy the close interaction and ensure efficient collaboration with our international business partners, including our global distributor Ethicon, a Johnson & Johnson company.
Working for a company the size of Ferrosan Medical Devices will at times demand a pragmatic approach, so you need to know when to apply a perfect solution and go with the best option available.
In summary, your role will include:
- Develop, communicate, and implement global regulatory strategies for medical device Class III / combination products.
- Liaise with global regulatory counterparts to ensure regional requirements are incorporated into the development of the product registration strategy. Coordinate with key partners to ensure timely and accurate submissions to regulatory authorities.
- Prepare global registration files including PMA supplements for FDA, such as 30 Days Notices, Real-Time Supplements, and 180-Day Supplements.
- Drive Regulatory Product Life Cycle Maintenance activities to support continuous product success through ensuring compliance with global regulatory post-market requirements in the +40 countries where our products are registered.
- Perform change management assessments, including assessment of changes in the manufacturing processes, to determine and communicate global post-approval reporting requirements.
- Monitor relevant legislation to ensure that Ferrosan Medical Devices is constantly in compliance with applicable law.
- Prepare and maintain regulatory standard operating procedures, ensuring compliance with relevant global regulations and guidelines.
- Contribute to and participate in internal education and training activities to ensure that your regulatory affairs expertise is shared as appropriate.
Depending on your profile, your role may also include:
- Ensure effective processes for the company’s post-market surveillance activities and adverse event reporting.
- Develop Post Market Surveillance Plans for the collection of post-launch data on device performance and safety.
- Prepare credible and robust systematic literature reviews on the clinical performance and safety of medical devices designed for hemostatic management during surgery.
- Write and update Periodic Safety Update Reports (PSUR), and Summary of Safety and Clinical Performance (SSCP).
- Ensure integration of post-market surveillance data into clinical evaluation reports (CER) and risk analyses.
Ideal candidate profile
You have a few years of regulatory affairs experience from the medical device industry where you have gathered broad regulatory experience and know-how from life cycle maintenance activities and/or product development projects. You have an interest or perhaps also experience with clinical evaluation reports and Post Market Surveillance activities and you keen on developing your skills further in these areas.
The role requires:
- The candidate has +3 years of experience in Regulatory Affairs from an international medical device company; ideally with class III / combination products.
- The successful candidate will have an academic background within life sciences (pharmacy, chemistry, human biology, engineering or similar).
- Extensive knowledge and understanding of US, EU, and global Medical Device regulations, standards, and guidance documents.
- Excellent writing skills, distilling complex information into clear and credible regulatory filings is a must.
- In your collaboration with your cross-functional colleagues, you understand when to take an assertive approach to deliver on critical regulatory tasks while also being willing to offer flexibility when considered appropriate.
- As a person, you are curios, self-driven with a “can-do” attitude who thrives in a dynamic environment.
- Preferably, you also have some experience with clinical affairs, post market surveillance and/or vigilance from the medical device / life science industry.
- Proficiency in English is a necessity.
Ferrosan Medical Devices as a workplace
Ferrosan Medical Devices A/S is driven by a dedicated energetic organization with impressive growth. Our company has 230 employees covering all aspect of tasks related to product development and production of medical devices and combination products.
How to come into consideration
Peoplement offers executive search and recruitment of executives, senior managers, and key specialists primarily within general management, sales, digital, marketing, finance, supply chain & operations, R&D, HR and IT.
DK 2900 Hellerup, Denmark