Regulatory Affairs Specialist
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Søborg
Regulatory Affairs Specialist
Grow or kick-start your carrier within regulatory affairs in Ferrosan Medical Devices A/S
A keen desire to make a difference and a strong analytical mind-set: These qualities are more important than the experience you bring to this important position in Ferrosan Medical Devices; a successful Danish MedTech company delivering hemostatic solutions for surgical procedures.
We offer an exciting and challenging role which entails an opportunity to obtain comprehensive experience and know-how within the field of global regulatory affairs for high-risk class medical devices and device-drug combination products.
Your role
As Regulatory Affairs 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 through ensuring regulatory deliverables in new product development / life cycle maintenance projects. Development of strong regulatory strategies and targeted/coordinated global filings are critical activities to support our Class III medical devices/combination products. You will have a wide degree of cross-functional interaction with skilled and dedicated colleagues from New Business Development, Product Development, Operations Support and Development, Supply Chain and QA/QC. You will also enjoy a close interaction and ensure efficient collaboration with our international business partners, including our US-based global distributor Ethicon, a Johnson & Johnson company.
The Regulatory Affairs Department consists of 7 experienced and dedicated colleagues. We will design a training program tailored for your needs to ensure that you build a solid foundation within regulatory affairs. This will include both internal training as well as external courses. We expect that you also pro-actively seek ways to continuously grow and learn, using both formal and informal development channels.
Primary responsibilities,
- Develop, communicate and implement global regulatory strategies for medical device Class III / Device-Drug 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.
- 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.
- 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 insights are shared across the organization as appropriate.
Qualifications
- The successful candidate will have an academic background within life sciences / natural sciences (biotechnology, human biology, chemical engineering, pharmacy or related field)
- Some knowledge/experience within regulatory affairs is an advantage, but not a must.
- Exceptional written communication skills are key: The ability to distill complex scientific information into clear and credible messages is a key discipline within regulatory affairs.
- Problem-solving skills are essential: A logical-analytical approach to dealing with complex matters and obstacles is a key quality to ensure identification of appropriate solutions.
- You possess a pro-active personality, characterized by your natural urge to take action and persevere to bring about meaningful change.
- High proficiency in English is a requirement. The ability to read & understand Danish is important, but it is not a requirement to possess written/oral Danish skills.
Working at Ferrosan Medical Devices
Ferrosan Medical Devices A/S is driven by a dedicated, energetic organization with impressive growth. The flat organizational structure attracts people who thrive on the development of the business and enjoy being close to decisions. Our company has 220 employees covering all aspect of tasks related to product development and production of medical devices and combination products. The position is new and will have reference to the Regulatory Affairs Manager.
Please submit your application including CV here no later than 13 April 2020. Mark the application "Regulatory Affairs Specialist". If you have any questions to the position, please do not hesitate to contact RA Manager Malene Barré Pedersen (53 55 35 01).
Information og data
Denne ledige stilling har jobtypen "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 16.3.2020, 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.
- Apoteker
- Søborg
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