Senior Regulatory Affairs Specialist – F/M

21/10/2024

Compensation and Logistics

  • Contact type: Full-Time Permanent Contract (CDI)
  • Status:  Executive
  • Location: Clichy (subway line 13 or subway line 14, high-speed train service linking Paris to the suburbs: line RER C, train L, bus 74 or 341…)
  • Benefits: luncheon vouchers (€8.50 per day worked), health insurance (employer pays 50%), provident fund (employer pays 100%), travel pass (employer pays 50%), 8 to 12 days of additional time off per year, 25 days of paid leave per year
  • Recruitment context: remplacement
  • Partial teleworking possible: 90 days per year
  • Available from: November 2024.

Please send your CV to: careers@corwave.com, reference « Senior Regulatory Affairs Specialist ».

Company description

CorWave is a medical technology start-up developing biomimetic implantable heart pumps with the mission to improve the lives of patients suffering from advanced heart failure.

The CorWave membrane pump is a breakthrough technology, protected by more than 50 patents, and the result of 20 years of research.

Funded by leading international investors and supported by renowned surgeons, CorWave aims to become a global leader.

More than 90 CorWavers from 13 different nationalities are driving this scientific, medical, industrial, and deeply human adventure.

Recruitment context

Are you looking for a new challenge in an innovative and dynamic company?

Join our committed team, which has transitioned from R&D to advanced industrial production.

Our mission: to design and manufacture ultra-high-performance and reliable heart pumps, dedicated to improving the lives of patients with advanced heart failure.

If you are motivated, ready to innovate, and excel in an agile environment, this adventure is for you.

Join us, where every heartbeat makes a difference!

Job description

As a Senior Regulatory Affairs Specialist, you will be responsible for developing and executing regulatory strategies to ensure the approval of our Class III left ventricular assist device (LVAD) in various markets, including Australia, Europe, and the United States.

This position involves close collaboration with cross-functional teams to ensure compliance with medical device regulations and manage submissions for clinical trials and commercial approvals. You will also develop, with the support of the QA team, internal procedures that comply with ISO 13485 and other relevant regulations.

You will be responsible for the following tasks:

Regulatory Strategy

  • Identification and synthesis of relevant regulations, standards, and directives for the LVAD system in different regions.
  • Development and implementation of strategies for clinical studies, product registration, and commercialization across multiple markets.
  • Analysis of the impact of design changes, process improvements, and new features, along with strategic recommendations.

Compliance and Quality System

  • Collaboration with the Quality Assurance team to ensure compliance with ISO 13485, 21 CFR Part 820, and other applicable regulations.
  • Design, implementation, and maintenance of robust regulatory processes and documentation to ensure compliance throughout the product lifecycle.
  • Anticipation and preparation for internal and external audits to ensure compliance and company effectiveness.

Cross-functional Collaboration and Risk Management

  • Close collaboration with R&D, Manufacturing, and Clinical teams to integrate regulatory requirements into development plans.
  • Provision of clear regulatory guidance to teams regarding compliance in product design, testing, labeling, and manufacturing processes.
  • Participation in risk management activities, including design reviews and hazard analyses.

Training and Continuous Improvement

  • Development and delivery of regular training sessions to enhance the compliance culture within teams.
  • Design and continuous optimization of regulatory processes, tools, and systems to increase efficiency and align with business objectives.

Marketing Compliance and Labeling

  • Oversight of the development of compliant labeling, promotional materials, and instructions for use according to regulatory requirements.
  • Assurance that all marketing materials comply with regulatory submissions and approved claims.

Clinical Trial Support

  • Assistance with all regulatory aspects of clinical trial planning, including protocol review and submission management to ethics committees and regulatory authorities.
  • Assurance of regulatory compliance during the conduct of clinical trials, including tracking and reporting adverse events and protocol deviations.

Regulatory Monitoring and Risk Management

  • Maintaining up-to-date knowledge of global regulatory requirements and developments that may impact Class III active medical devices.
  • Conducting continuous regulatory monitoring and anticipating potential obstacles to minimize product development risks.

Submissions and Regulatory Agency Relations

  • Preparation and submission of regulatory dossiers (IDE, PMA, 510(k), CE Marking, etc.) to ensure rapid and successful approvals.
  • Collaboration with global regulatory agencies to manage pre-submission meetings and respond to information requests.

Team Leadership and Development

  • Establishing and managing a high-performing regulatory affairs team to effectively support CorWave’s activities.
  • Defining clear roles and responsibilities, setting measurable objectives, and mentoring team members for their professional development.
  • Overseeing workload distribution and resource allocation to effectively meet submission deadlines and compliance requirements.
  • Promoting a collaborative environment and encouraging a culture of regulatory excellence within the team.

Qualifications

  • Minimum of 5 years of experience in regulatory affairs for Class III active implantable medical devices and their accessories.
  • Bachelor’s degree in a scientific discipline, engineering, or a related field (higher degree is a plus).
  • Proficiency in English, both spoken and written, is essential for this role (international environment). Proficiency in French, both spoken and written, is a plus.
Specific Knowledge
  • Knowledge of Australian, European, and FDA regulatory processes, with a proven track record in submissions for clinical trials and product approvals.
  • Understanding of ISO 13485, 21 CFR Part 820, and other standards for medical devices.
Technical Skills
  • Experience in developing regulatory strategies for active implantable devices, ideally in cardiology.
  • Strong project management, communication, and problem-solving skills.
  • Ability to lead regulatory initiatives and collaborate with cross-functional teams.
  • Willingness to assume leadership responsibilities, support the team, and contribute to its growth.
People skills
  • Organization
  • Attention to detail
  • Communication
  • Leadership
  • Positive attitude.

Recruitment Process

  1. Pre-qualification (telephone or on Teams)
  2. Manager interview (on Teams or on site)
  3. Interview +Workshop
  4. Taking up references.