Head of regulatory & compliance
Regulatory & Compliance – Stockholm
This is not an average regulatory or compliance job.
This is the job, which will enable the massive value shift from pharma to technology - from drugs to data.
This position represents the regulatory challenge of the next decade - how to innovate with technology within health. A trillion dollar industry in the making, which requires a combination of legal experience, hard work, creativity and communication skills.
Regulatory & Compliance are often seen as something boring that does not attract the top talent. This could not be further from the truth at Natural Cycles.
What you will be doing
You will work closely with the CEO and other members of the management team to ensure overall compliance with regulatory requirements, new regulatory filings for market access in new countries or of new products, as well as legal investigations. You will be responsible for building the team and the project teams to succeed on this mission. Together with the CEO, you will contribute to infuse a company culture that embraces the power of documentation and legal frameworks.
- Defining and implementing procedures and documentation in line with regulatory requirements (medical device & GDPR for now). Overall responsible for quality system (medical device file, SOPs, quality records)
- Project manage regulatory filings into new countries (outside EU & US) as well as regulatory filings for new product
- Manage and drive audits from authorities & notified bodies
- Manage and drive internal audits
- Liaise with other regulatory/governmental agencies (consumer protection, data protection, competition,...) and own legal crisis.
- Assess and monitor legal risk
What experience & skills you should have
- Lawyer with minimum 3 years experience at reputed law firm (or equivalent)
- You then worked operationally in a regulated environment in a company, ideally digital company (fintech, biotech, pharma) within compliance, risk or legal.
- You have project management skills and worked with highly specialized people (scientists, developers,...)
- You have managerial and hiring experience
- You are great at writing, structuring and organizing
- High intelligence - capable to connect the dots from helicopter view down to the nitty gritty detail.
- You have high confidence when interpreting the law, you have respect for the law, you have passion for documentation and you understand the power behind documentation.
Only applications in English and through the website will be considered. Interviews and all contact will be held in English.