DESCRIPTION OF THE COMPANY
TISSIUM is a privately-owned medical technology company founded in 2013 and developing biomorphic programmable polymers for atraumatic tissue repair and reconstruction. It is headquartered in Paris, with a production facility in Roncq (near Lille) and an office in Boston.
Currently, the company has a pipeline of seven products across three verticals, including peripheral nerve repair, hernia repair, and cardiovascular sealing.
The company's technology is the result of research and intellectual property from the laboratories of Professor Robert Langer (MIT) and Professor Jeffrey M. Karp (Brigham and Women's Hospital) developed by the company’s co-founder and Chief Innovation Officer Maria Pereira. Christophe Bancel, co-founder, and CEO of TISSIUM, has led the charge since inception, directing the company as it has conducted R&D, various clinical trials, and fundraising efforts resulting in €170 million in funding for the company.
At TISSIUM, we are driven by the conviction of our ability to innovate, our resilience and ability to work collaboratively to develop solutions that benefit patients' lives. Joining Tissium means participating in a human adventure, in a stimulating and fast-growing environment, while helping to build a future leader in its field.
We are actively looking to recruit a Regulatory Project Manager to be part of Tissium’s Regulatory Department.
The Regulatory Project Manager is responsible for managing and executing the company’s regulatory approval strategies, ensuring that the company meets applicable medical device legislation and ensuring that the company’s products meet all applicable regulatory requirements.
Duties & Responsibilities
- Lead the submission task force to support regulatory submissions and interactions for assigned projects. This includes planning, preparation, drafting and delivering regulatory submissions.
- Work with cross-functional teams throughout the product development to ensure compliance with the chosen regulatory strategy.
- Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
- Provide regulatory insight and advice to teams internally on new/updated regulatory requirements.
- Participate in internal or external audits.
- Conduct regulatory intelligence/research to maintain and develop knowledge of the global competitive landscape, regulatory environment, and regulations.
- Participate in evaluating changes to current products based on regulations.
- Maintain regulatory files as necessary to sustain product approval.
The Regulatory Project Manager will report to the Director, Regulatory Affairs.
YOU WILL LOVE THIS JOB IF
- You are a self-starter, energetic, motivated.
- You are positive attitude; proactive approach to problem solving, reliable and outcome driven.
- You possess the ability to multitask, detailed oriented and critical judgment.
- You are disciplined and very well organized.
- You are persuasive and diplomatic.
- You are highly committed personality and a desire to achieve.
- Bachelor’s degree.
- At least five (5) years of regulatory affairs experience in the medical device industry, ideally in class III medical devices.
- Excellent communication skills (written and verbal) in English and at least one other European Language preferably French.
- Proven hands-on experience in preparing and reviewing submission packages and interaction with competent authorities in the USA and at least one other global area.
- Excellent understanding of the world-wide regulatory requirements of implantable medical devices.
- Ability to provide regulatory input and leadership to cross-functional project teams.
WHY JOIN US
- An opportunity to join an ambitious start-up addressing one of the most persistent medical challenges since the inception of surgical procedures.
- Fast-moving environment - you will never stop learning and growing.
- International environment - the team is composed of more than 13 different nationalities. Diversity is a strength at Tissium.
- Work on-site in Paris, Roncq or Remote-flexible.
- Competitive salary package & benefits.
- Last but not least, strong company culture with transparency as one of our values - information is shared regular with the team!
- The journey starts with an interview with Talent Acquisition Manager (30 mins)
- Then a face-to-face (virtual) meeting with the Manager of the department you are applying to join (1 hour)
- This will then be followed by a case study or business case to validate your practical job-related skills ( 1hour)
- For the very final round, you will meet other teams in Tissium
- You will be asked to provide us with professional references including contact details.
Intrigued? We’d love to hear from you! Apply today — we’re standing by for your resume!
👉 We believe that, in order to create a company for everyone, we must also guarantee that it is built by a diverse team. We embrace diversity and invite applications from people from all walks of life. We don't discriminate against employees or applicants based on gender identity or expression, sexual orientation, race, religion, age, national origin, citizenship, disability, pregnancy status, veteran status, or any other differences. We are very process-light, putting human interactions above and making sure that everybody is heard.