Regulatory Affairs Director
(QM & RA department)
Ferrosan Medical Devices A/S
Ferrosan Medical Devices is currently working with long-time partner and customer Ethicon on innovation projects to address current market needs exploring new trends and possibilities for creating a sustainable business for the future. You will be heading the total RA department and work closely with Ethicon to ensure allignment.
We are looking an RA Director holding strong people management skills as well as RA skills, wanting to impact Ferrosan MD’s future as well as the daily business in a very important and central management role for the company.
Your department currently consists of 7 RA professionals including 1 employee responsible for Post Marketing Surveillance (PMS).
Being on an innovation journey requires more RA professionals and therefore you will be hiring additional headcounts.
The RA Director will be heading the RA department and is a member of the extended management team. You will be reporting to VP for QM & RA, member of the management board.
Working for a company with around 230 employees 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. We guarantee that you will join a company with no time for unnecessary politics or rigid processes, making decision making quicker and smoother and work satisfaction much higher.
In summary, your role will include:
- Link between RA and other departments. Ensure holistic efforts pertaining to RA’s contribution to overall company objectives while contributing to the work environment in both RA and the organisation.
- Daily operations in RA including among others maintaining product registrations, updating packaging artwork, participating in project work.
- Producing and maintaining regulatory submission including strategic perspectives.
- Planning regulatory strategies and identifying and addressing regulatory risks.
- Monitoring of relevant legislation to ensure that FeMD is constantly in compliance with applicable law.
- Ensuring the updating and effective functioning of quality systems in own unit.
- Overall responsibility for FeMD’s PMS activities to ensure that PMS activities are handled in accordance with applicable law and FeMD internal standards.
- Ensure continuous improvements of the quality system for PMS, effective processes, and Medical Device Reporting.
- In connection with project participation, RA is responsible for drafting RA strategies for use in the project including assessment of risk and verification of presumptions and their continuous updating in relation to most recent knowledge and development in the project.
Ideal candidate profile
You have gathered RA experience perhaps from a larger company and you are looking to join a dynamic company with an exiting innovation journey where you represent the RA department across the existing product line and the innovation projects.
You have line management experience and a background in pharmaceuticals, engineering, or other relevant background from the natural sciences, and you have 3 – 4 years’ experience with Regulatory Affairs including the filing of registration files with EMA, FDA and Notified Bodies. Furthermore, you have extensive knowledge of American and European legislation with regards to pharmaceuticals/biologics, medical devices and combination products.
The role requires:
- Strong RA competences, people management skills and strategical skills
- Solid coaching skills to support and strengthening employee’s development
- Ensuring the right balance between professionalism and pragmatic approach
- The best prioritizing of resources and efforts of your department
- Taking ownerships for decisions in collaboration with stakeholders
- Capabilities in delivering on the whole RA spectrum from innovation project to improving RA processes and handing compliance issues
- Excellent collaboration skills also with external stakeholders
- Taking and enjoying responsibility in the role and good at delegating
- Strong commercial understanding as you will impact many strategic decisions for the company
- Good at communicating your view and landing a solution with others
- Strong at building a high performing team delivering on targets
- Strong interpersonal skills, self-starting and collaborating personality
- Strong oral/written communication skills both Danish and English
- Ability to put own work into a cross-functional reference
- Structured, good overview and ability to deep dive into detail when necessary
- Preferably master’s degree
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.
Ferrosan Medical Devices as a workplace
An international organization with about 230 employees and a strong collaborative culture with solid Danish roots. An environment where you discuss matters with your colleagues and key stakeholders and can expect everyone to take responsibility for common results. The organization is flat and tone informal.
The role is based in Søborg, DK.
How to come into consideration
Peoplement offers executive search and recruitment of executives, senior managers, and key specialists primarily within IT, general management, sales, digital, marketing, finance, supply chain & operations, R&D and HR.
DK 2900 Hellerup, Denmark