Regulatory Affairs Specialist M/F/X

DESCRIPTION OF THE COMPANY

Tissium is a mission-driven medical device company founded in 2013 headquartered in Paris with a production facility in Roncq (near Lille) and an office in Boston. We are dedicated to creating a new era of body repair by leveraging our biopolymer platform to develop innovative surgical solutions for a positive impact on patients lives.

Tissiums technology is based on research and intellectual property from the laboratories of Professor Robert Langer (MIT) and Professor Jeffrey M. Karp (Brigham and Womens Hospital) who co-founded the company with Christophe Bancel (CEO) and Maria Pereira (Deputy CEO & Chief Innovation Officer).

We are developing polymers for atraumatic tissue repair in various applications. Today these polymers are used for structureless nerve repair hernia repair and cardiovascular sealing.

Since our inception we have raised a total of 170 million. Our latest fundraising round in April 2023 brought in 50 million in additional funding. This capital provides the resources to finance the commercialization of our first products.

About the Role

We are seeking a Regulatory Affairs Specialist to join Tissiums Regulatory Department and contribute to our mission of creating a new era in body repair.

In this role you will play a key part in executing our regulatory strategy ensuring compliance with applicable medical device legislation and making sure our innovative products meet all relevant regulatory requirements worldwide. Your work will directly support the safe and effective delivery of our solutions to patients and healthcare providers.

Key Responsibilities

• Lead the Regulatory Intelligence Program to monitor assess implement and communicate regulatory changes affecting the companys products and markets.
• Provide regulatory insight interpretation and advice to R&D teams internally on new/updated regulatory requirements.
• Support the global regulatory strategy of our existing products or products in development.
• Collaborate cross-functionally to ensure regulatory requirements are integrated into product design and lifecycle management.
• Compile and support the preparation of regulatory submissions including but not limited to EU Technical Documentation FDA Pre-submission documents IDE applications pre-market notifications/applications and post-market reporting.
• Ensure that all CE marking and registration documents (including compiling product technical file) are complete and up to date.
• Participate in internal or external audits.

REPORTING LINE

This job will report to the Senior Director Regulatory Affairs.

YOU WILL LOVE THIS JOB IF

• You have strong analytical organizational and communication skills.
• You can work collaboratively in a cross-functional international environment.
• You are highly committed and have a strong desire to achieve.
• You have excellent communication skills both written and verbal in English.

YOUR BACKGROUND

• Degree in Regulatory Affairs science engineering or another technical discipline.
• 13 years of experience in regulatory affairs or R&D within the medical device sector or other relevant education/experience.
• Proven technical expertise in the ISO 60601 series and compliance requirements for electronic medical devices.
• Solid understanding of EU Medical Device Regulation (MDR) and relevant guidelines.

WHY JOIN US

• Thrive in a stimulating environment with a work culture that values urgency a willingness to take risks a passion for learning the ability to challenge the status quo and the agility to operate in a dynamic setting.
• Grow your career: At TISSIUM we invest in our people through tailored training and professional development programs. We believe in offering diverse learning methods to help each team member flourish in their career journey.
• Be part of an ambitious start-up tackling one of the most persistent medical challenges since the advent of surgical procedures.
• Work with purpose: Environmental Social and Governance (ESG) principles have been embedded in our business model from the very beginning. As we grow strengthening and advancing our ESG strategy and commitments remains a top priority.
• Enjoy competitive benefits: Work-life balance Flexible remote work options Attractive total compensation Internal and geographic mobility opportunities across our locations (Paris HQ Boston office and Roncq industrial site).
• Join a truly international team: Collaborate with colleagues from over 19 nationalities reflecting TISSIUMs commitment to diversity and the strength it brings to our work.

HIRING PROCESS

• The process begins with a 30-minute interview with our Talent Acquisition Manager.
• This is followed by a one-hour interview with the hiring manager.
• For the final stage you will meet with other members of the Tissium team for a team and culture fit interview.

In some cases we may also request professional references including contact details.

Intrigued Wed love to hear from you! Apply today were standing by for your resume!

We firmly believe that building a company for everyone requires a diverse team. Our organization values diversity and welcomes applications from individuals of all backgrounds. We do not 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.

Our company culture prioritizes human interaction and ensures that every individuals voice is heard making our processes lightweight yet efficient.