Regulatory Affairs Specialist

About the job

At KLISBio, we challenge the status quo in regenerative medicine by leveraging silk as a powerful and biocompatible scaffold material.

Our most ambitious goal is to redefine how hard-working in situ tissue engineering is performed, disrupting, with our silk-based technology platform, the solutions through which regenerative medicine is delivered to patients.

The new team player

Are you passionate, hard-working, and eager to learn from an RA specialist work opportunity?

Our ideal candidate is motivated to work in a fast-paced startup and has a strong desire to grow in a very dynamic and exciting environment.

You will be part of the Regulatory Affairs and Quality Assurance Team. In this role, you will combine your knowledge of scientific, legal and business issues to ensure that the medical devices that KLISBio Srl develops, manufactures or distributes, meet the required legislation and are fit for purpose; you will enhance your abilities to work in a team, meet schedules and goals. You’ll have a chance to put your hands on a variety of activities among different areas of interest and soak in all the knowledge from the diverse teams you’ll be collaborating with.

Your tasks

Reporting directly to the Head of QA/RA, you will be responsible for regulatory activities concerning the Company’s products in the USA, Europe, and others. Therefore, you will be:

• Responsible for registrations of the Company’s products in the USA, Europe, and others:

- Propose strategies for the earliest possible approval of regulatory submission;

- Propose strategies for regulatory pathways in the US and Europe for the products in the pipeline.

- Explore the competitive landscape to find the closest predicate devices and comparable regulatory dossiers in collaboration with R&D and Marketing Teams;

- Oversee short-term and long-term planning of regulatory submission initiatives;

- Manages the relationship with consultants and coordinate the internal workstreams to prepare for regulatory filings, such as 510(k)s, Pre-Subs, CE marks and others;

- Coordinate and prepare document packages for regulatory submissions ensuring compliance with the FDA Authorities and EU Notified Bodies

- Prepare and submit applications;

- Support the top management in the engagement directly with the FDA and other regulatory bodies, in particular by focusing on how to further optimize the approval process and negotiate with regulatory authorities for marketing authorisation.

• Responsible for maintaining registrations:

- Prepare and submit safety reporting documents;

- Prepare and submit post-market reports;

- Prepare and submit changes communications;

- Prepare and update labelling.

• Responsible for the following QMS processes (including procedures and records):

- Labeling;

- Monitoring of Laws, Regulation, Standards and Guidance;

- Regulatory compliance;

- Safety Reporting.

• And, more in general:

- Constantly monitor standards, regulations and guidance to maintain company compliant with the regulations of the regions where KLISBio want to distribute its products, and updated to the state of the art;

- Advice engineering teams on device-related regulatory aspects;

- Support cross-functionally the R&D function with regulatory inputs;

- Approve promotional materials;

- Review some clinical studies documents;

- Collaborate in the fulfil of legal requirements for the logistical delivery of medical devices on the market;

Our ideal candidate is:

As RA Specialist: good written and oral communication skills, an understanding of both legal and scientific matters, ability to take in complex technical information and make sense of it, analytical and problem-solving skills, attention to details, strong negotiation skills, IT skills (particularly in relation to using databases and familiarity with commercial software), project-management skills, good time management, ability to work under pressure and to strict deadlines, confident to report to management.

As KLISBio team member: very quick learner, proactive, pragmatic and goal-oriented. Hard-worker and collaborative, able to work effectively in team and interact with colleagues of different areas.

Additional requirements:

• Master’s Degree in scientific disciplines (in a biomedical, biopharmaceutical or life sciences area)
• Knowledge of Regulatory landscapes for medical devices
• Previous experience (5+ years) in RA departments of medical devices or pharma companies
• High proficiency in English, both written and spoken (C2);
• Excellent computer skills
• Knowledge of medical terminology
• MDR 2017/45
• 21 CFR 800-898
• 21 CFR 11
• Pre-clinical studies
• Biocompatibility according to ISO 10993
• US and Europe regulatory pathway to achieve approval to place the medical devices on the market
• Writing Standard Operating Procedures (SOPs) and other relevant documents

Nice to have:

• Previous direct experience with regulatory submissions
• Previous direct interaction with competent authorities

Next step

You feel referred and would like to move more with us. Please use the "Apply" button to upload your complete application documents online, ideally in English (cover letter, CV and relevant references).

About KLISBio

KLISBio is a clinical-stage regenerative medicine company. We are developing several innovative technology platforms based entirely on natural silk fibroin, which allow for the creation of various solutions for endogenous tissue repair and regeneration. KLISBio has several assets under development, such as nerve repair (close to be on the market), vascular graft, bone graft substitutes, rotator cuff repair, drug release.

Our vision

We are driven by the desire to innovate and redesign therapeutic approaches to help improve people's sensory perception and everyday functional activities that define the quality of the life they live.

Our mission

Our strongest goal is to remodel the way in situ tissue engineering is performed, disrupting the solutions through which regenerative medicine is delivered to patients, by using the most natural and renowned biomaterial.

Our philosophy

We believe in commitment, effort and goodwill to establish long lasting and trustful relations.

We truly think the secret of success is preserved within the people we work with and for this reason we invest in the well-being and development of our team. Our values and ethical approach are strongly perceived from the outside as a must to work together to improve the lives of others, creating wealth based on scientific progress.