AdressA Junior Regulatory Affairs Engineer with a strong desire to learn and with a hands-on, proactive approach. This person will play an important role in supporting our compliance activities working closely with both internal and external actors. A future star who will be organizing, documenting, and supporting all aspects of product compliance throughout its lifecycle. In this role you will also be supporting the regulatory team with product safety and compliance. You contribute to Ascom's success by maintaining regulatory access to key markets. This role is based in Gothenburg office.
What you will be doing ...
- Obtain, organize, file and retrieve regulatory evidence of compliance.
- Stay updated about applicable regulatory and quality requirements; monitor standards and legislation regarding product safety, certification, and conformity.
- Support product and service development teams to ensure compliance to design controls and design and development processes.
- Support in maintaining regulatory conformity, certifications and approvals for assigned products developed or supplied by Ascom including regulatory requirements for product approval and certification for intended markets.
- Maintain relationships with test houses, third party suppliers, partners, auditors, etc. and support in managing tests, audits and regulatory compliance with different external parties.
- Participate in and support internal and external quality audits in coordination with the Quality System Manager.
Our Ideal candidate has ...
- Bachelor's degree in Engineering, Information Technology, or equivalent education.
- Ability to work both independently and in teams.
- Good analytical and problem-solving skills.
- Good interpersonal skills with the ability to create and maintain relationships with test houses, third party suppliers, auditors etc.
- Good communication skills with the ability to collaborate and communicate with external parties in a formal manner, requiring high degrees of tact, diligence and professionalism.
- Good computer skills, specifically Microsoft Office and tools used for product creation, quality assurance and compliance
- Ability to multitask product, project and region / site level priorities.
- Good knowledge of English language, speaking and writing.
What we offer you ...
- A company you can take pride in
- Inspiring and collaborative colleagues
- Abundant opportunities for personal and professional growth
- The chance to work for a company with cutting-edge technology in the mobility and healthcare industry.
We are ...
Ascom is a global solutions provider focused on Healthcare ICT and mobile workflow solutions. Headquartered in Switzerland, our business spans across 18 countries, and has been supporting the healthcare industry for 160 years by providing them with technology to enable them to support their communities.
Our systems are used in over 12,000 hospitals worldwide and handle more than 800 million alerts each year (over 2 million alerts a day!). Our solutions positively impact the lives of everyone who visits 1 of the hospitals or care-homes we work with.
Together we can make a difference in the lives of the people who benefit from our technology.
To learn more about what we do, visit us at: www.ascom.com
Department Quality & Regulatory Locations SE Gothenburg Remote status Hybrid
