Contract: CDI, permanent
Location: Paris, France
At TISSIUM, we are creating the future of tissue reconstruction. Our team pushes the limits every day to design next-generation products based on our platform of biomorphic programmable polymers. We are disrupting the field of surgery, both open and minimally invasive, to positively impact the lives of patients.
We are actively looking to recruit a Regulatory Affairs Specialist to be part of Tissium’s Regulatory Department.
The Regulatory Affairs Specialist supports the execution of the company’s regulatory strategy, ensuring that the company meets applicable medical device legislation and ensuring that the company’s products meet all applicable regulatory requirements.
Duties & Responsibilities
- Support for the global regulatory strategy of our existing products or in development.
- Cooperate with R&D department throughout the product development to ensure compliance with the chosen regulatory strategy.
- 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.
- Conduct regulatory intelligence/research to maintain current knowledge base of existing and emerging regulations, standards, or guidance documents and recommend changes to company procedures in response to changes in regulations or standards.
- Provide regulatory insight, interpretation and advice to R&D teams internally on new/updated regulatory requirements.
- Participate in internal or external audits.
Qualifications & Skills
- Degree qualified in regulatory affairs, scientific, engineering or a technical discipline.
- One (1) to three (3) years of regulatory affairs experience in the medical device field or other relevant education or experience.
- Excellent communication skills (written and verbal) in English and at least one other European Language preferably French;
- Understanding of EU Medical Device Regulation and relevant guidelines.
- Understanding of ISO Standards (13485) (FDA CFR Title 21 desiderable).
Job Competencies & Personal Attributes
- Self-starter, energetic, motivated;
- Positive attitude;
- Result and quality oriented approach;
- Ability to multitask & Analytical thinking;
- Highly committed personality and a desire to achieve.
The Regulatory Affairs Specialist will report to the Head of Regulatory Submissions. The position is based in Paris, France. To apply to this position please email your CV to email@example.com. REF.202103-004