Job Description
Senior Director Device Regulatory Affairs:
This is a rare opportunity to join a young, exciting clinical-stage biotechnology company focused on the discovery and development of novel therapies with the potential to fundamentally change the course of progressive, debilitating diseases.
The company has experienced highly successful rapid growth in 2023, and this role will play a critical part in shaping the future of regulatory affairs.
The Senior Director Regulatory Affairs Device will be responsible for leading all regulatory activities for medical device and combination products, ensuring compliance to relevant standards such as ISO 13485 and FDA QSR.
This is a hybrid role based in Dublin HQ, reporting directly to the Chief Regulatory Officer.
Key Responsibilities:
* Define the global regulatory strategy for medical device products, working closely with cross-functional teams.
* Plan, submit, and maintain technical files and regulatory dossiers for clinical trials and marketing applications.
* Lead/support planning and execution of regulatory agency meetings/communications and scientific advice processes.
* Manage CE Marking of medical devices, including notified body selection and QMS audits.
* Work with the Head of Quality to develop and maintain the company's Quality Management System.
* Ensure compliance to applicable global regulations and standards.
* Provide technical regulatory support to the device development team.
* Support interpretation of regulations, agency guidelines, and standards, and translation into design requirements.
* Review and approve relevant documentation, including user needs, design input requirements, risk management documentation, and labelling.
* Support Risk Management process integration into the device development lifecycle.
* Input to the development of device labelling, instructions for use, and patient/user-facing material.
* Support Human Factor testing and integration of results.
* Liaise with CMC and Clinical functions regarding regulatory strategy and submissions.
* Assess the impact of changes in global regulations on products, processes, and procedures.
* Support post-market surveillance processes and reporting of device malfunctions.
* Oversee the development and management of Clinical Evaluation Plans and Reports.
Requirements:
* Bachelors or Graduate degree qualification in Science, Engineering, or related field.
* 10+ years' experience in medical device/combination product development and regulatory affairs.
* Proven experience with US, EU, UK, and other global markets.
* Knowledge of EU MDR 2017/745, ISO 13485, 21 CFR Part 820, and FDA QSRs.
* Experience interacting with third-party service providers.
* ISO 13485 Lead Auditor experience desirable.
Desirable Skills:
* Self-motivated with the ability to work in a fast-paced environment.
* Adept at balancing detail-oriented tasks with big-picture thinking.
* Creative, flexible, and innovative team player.
* Excellent written and verbal communication skills in English.
* Strong organizational, planning, problem-solving, and decision-making skills.
* Ability to perform multiple tasks simultaneously and prioritize workload.
* Maintain a professional and positive attitude and present clear instruction/direction to team members.
This is an exciting opportunity for a driven and passionate individual to take on a key leadership role in shaping the future of our company's regulatory affairs. If you are a self-starter with a strong track record in medical device regulatory affairs, we encourage you to apply.