RA Drug Specialist
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 (Surgiflo®. 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 with drug background to take overall responsibility for ensuring that product registrations in all markets are compliant with the applicable regulations (EU, USA, Japan, Canada, Australia, and other relevant countries). Being on an innovation journey and MDR and more devices in the pipeline requires more requires more RA employees and therefore we are hiring an experienced RA Specialist experienced with drug, regulatory filing and CMC documentation. The department consists of 7 RA FTE’s including 1 employee responsible for Post Marketing Surveillance (PMS). You will report to the RA Director.
Your will be overall responsible for maintaining and meeting the drug dossier requirements handling submissions to The European Medicines Agency (EMA). You consult with notified body acting as applicant on behalf of Ferrosan Medical Devices. You will be given many versatile tasks in a dynamic environment where many factors come into play.
A strong relationship with our external partners is important to ensure success in this role. You will be working closely with Omrix Biopharmaceuticals, based in Israel regarding the drug submissions. Omrix produces and delivers thrombin, the biological drug, used in our combination product. You will also work closely with Ethicon, our long-time partner and main distributor, based in the US.
Our device-drug combination product (class III) has high level regulatory complexity which is why we are looking for a highly skilled professional eager to make a difference. Your professional assessment and understanding of drug regulation and CMC are key to fill the role successfully.
You will also be involved in regulatory support in projects such as change request cases and early and later stage development projects. You will advise on appropriate RA strategies relevant to the project and continuously keep the project team updated in accordance with the latest knowledge and development in your area.
Working for a company the size of Ferrosan Medical Devices will at times also 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:
- Responsible for ensuring maintenance of product registrations for all markets where Ferrosan Medical Devices products are distributed.
- Ownership for the registration dossier and CMC registration documentation.
- Participate in project work, including development of new products and preparation of RA strategies in connection with project work.
- Defining regulatory strategies and identify regulatory risks and risk mitigations.Participate in Design Control and packaging activities.
- Regulatory impact assessments on Change Requests.
- External contact to international stakeholders and notified body.
- Write and update RA documents and set the necessary standards.
Ideal candidate profile
Ideally you have CMC and RA drug experience from a similar role where you have been responsible for the registration dossier also writing the CMC registration documents liaising with business partners and notified body.
If you have experience with RA activities related to developing and maintaining a class III medical device incorporating a drug this will be an advantage.
You are confident speaking and expressing yourself in English as you will be communicating daily with Ethicon and Omrix Biopharmaceuticals as key external stakeholders in your role. You are used to work independently but also in collaboration with other functions with the ability to communicate complex issues in a clear way for everyone to understand.
The role requires:
- The successful candidate will have an academic background within life sciences (pharmacy, chemistry, human biology, engineering or similar).
- The candidate has +5 years of experience in Regulatory Affairs and drugs preferably in a biopharmaceutical context.
- Experience from an international medical device company; ideally with class III / combination products is an advantage.
- Extensive knowledge and understanding of US, EU, and Global drug 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. Your strong expert level within the field of regulatory affairs, makes it easy for you to make this judgement on a case-by-case basis.
- Experience with ISO 13485, MEDDEV 2.7/1, FDA 21 CFR part 800-898 and MDD/MDR is an advantage.
- As a person, you are curious, pragmatic, self-driven with a “can-do” attitude who thrives in a dynamic environment.
- Fluency in Danish and high proficiency in English both oral and writing is a necessity as partners are international.
- Strong analytical skills, attention to details and ability to clearly understand and communicate information.
- As a person, you are curios, self-driven with a “can-do” attitude who thrives in a dynamic environment.
- Strong interpersonal skills, self-starting and collaborating personality.
- Ability to put own work into a cross-functional reference.
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