Your job in a nutshell

As a Legal & Compliance Officer your responsibility is to ensure that the company operations and business transactions follow all relevant laws, regulations, and ethical standards as well as internal rules, at all levels of the company. You will identify and eliminate the risks of non-compliance, both externally and internally, and will act as the SME and responsible for legal and ethical compliance and GDPR.

As part of your role, you draft and review agreements that the company aims to enter into (whereby if needed support from external legal advisor is consulted) that relate i.e. to collaboration, study, purchasing and supply, maintenance, quality and commercial agreements.

The Legal & Compliance Officer is appointed as Associate Data Privacy (ADP) within the company.

Together we ensure the validation and implementation of clinically relevant scientific discoveries into reliable medical diagnostic assays for diagnosis, prognosis and drug effectiveness prediction that will ultimately contribute to improved patient care.

Essential Duties and Responsibilities

• Draft and review agreements.

• Draft and revise company policies based on latest applicable regulations and business needs.

• Create and improve system and processes to ensure legal and ethical compliance.

• As ADP, your are responsible for ensuring compliance of the data processing within SkylineDx with internal privacy policy and relevant legislation, advising on and monitoring the implementation of Data protection impact assessment (DPIAs) and reviewing /maintaining the Data Processing Register.

• Create internal controls and monitor adherence to those policies.

• Conduct regular audits to identify potential weaknesses and noncompliance situations.

• Collaborate with the QA department to set plans to address noncompliance situations and creating realistic plans to overcome them and prevent them.

• Report to management concerning the organization’s compliance with laws and regulations.

• Address employee concerns or questions on legal compliance.

You have

• a bachelor’s degree in law, business administration or a related field.

• at least 3-5 years of experience in healthcare compliance.

• a proven experience as a Compliance Officer or Compliance Manager in healthcare sector.

• experience with compliance audit and risk management.

• knowledge of relevant regulations and laws applicable to the industry, including national and European GDPR, and preferably also Interaction with health care professionals, HIPAA, and FDA

• knowledge of legal and ethical requirements in healthcare products, branding, and working with healthcare professionals and institutes.

• strong communication and interpersonal skills.

• integrity and professional ethics.

• the ability to analyse complex information and make informed decisions.

• a hands-on mentality and result oriented attitude.

• a creative approach to problem solving. an excellent command of the English language.

• affinity with our corporate quotes (must).

• an entrepreneurial mind-set and are able to work in an environment with high quality standards.

• the ability to motivate the team and manage both internal and external collaborations.

We offer

• a full-time position (minimum 32 hours per week), a market competitive salary and market competitive secondary conditions of employment.

• opportunities for personal growth.

• the best of two worlds: a career in life sciences at an innovative biotech company with the emphasis on clinical diagnostics in close collaboration with an academic environment.

• the ability to serve society with science based solutions.

At SkylineDx

We live to make a difference. It is our mission to improve a patient’s quality of life by enabling them to benefit from personal insights at the genomic level of their disease. That means we are continuously innovating the world of gene signature-based diagnostic testing. That also means we have a unique blend of characteristics. We have our soft side. Our culture is oftentimes described as familial, warm, loyal and highly engaged. We have our rational side where exact sciences are driving our mission. And when needed our passionate side surfaces to clear the way so we can serve society with science based solutions.

Our quotes

#serviceisjoy

#valueformoney

#playtogethertowin

#amazingthingshappen

#cogitoergosum

#itsyourparty

Do apply!

Send your resume and motivation letter to Soraya Mestar (HR) at hr@skylinedx.com. If you have questions or want more information, don’t hesitate to contact us. You’ll find the contact details here on our website. We will make sure it lands on the right desk!