Director Regulatory Affairs - Device

Senior Director Device Regulatory Affairs

This is a rare opportunity to join a young, exciting clinical-stage biotechnology company.

Our client is focused on the discovery and development of novel therapies, with the potential to fundamentally change the course of progressive, debilitating diseases. 2023 has been a year of highly successful rapid growth in the company.

The preferred candidate will bring passion, energy and enthusiasm. An entrepreneurial business-oriented mindset and a strong fit with company ethos. Agility and versatility are essential traits. The role of Senior Director Regulatory Affairs Device will be filled on a permanent basis.

The role is hybrid role based in Dublin HQ.

Reporting to the Chief Regulatory Officer, this role will be responsible for all regulatory activities for medical device and combination products, including defining the device regulatory strategy and overseeing all device submissions across global markets. They will lead key elements of regulatory systems, ensuring compliance to relevant standards for the business including ISO 13485 and FDA QSR.

Key Duties and Responsibilities:

· Define, in partnership with the cross functional team, the global regulatory strategy for medical device products for investigative clinical trial as well as marketing applications.

· Effectively work on cross functional teams (especially with key partners such as CMC, Device Development and Supply Chain) to plan, submit and maintain technical files and regulatory dossiers in support of clinical trial and marketing applications for device and combination product submissions.

· Lead/support planning and execution of all regulatory agency meetings/communications and scientific advice processes.

· Manage the CE Marking of medical devices, including notified body selection, QMS audits and technical file compilation and audit.

· Working with the Head of Quality, support the development and maintenance of the company’s Quality Management System and foster a culture of quality & compliance.

· Ensure compliance to applicable global regulations and standards (e.g. EU MDR, US FDA, 21 CFR 820, ISO 13485:2016)

· Provide technical regulatory support to the device development team.

· Support the interpretation of regulations, agency guidelines and standards, and translation into design requirements to ensure compliance.

· Review and approve relevant DHF documentation (e.g. user needs, design input requirements, risk management documentation, design V&V reports, labelling, etc.).

· Support the application of a Risk Management process to the device development lifecycle.

· Input to the development of device labelling, instructions for use and any patient/user facing material.

· Support Human Factor testing and integration of results into program

· Review of design verification and validation protocols and reports.

· Liaise with the CMC and Clinical functions with respect to regulatory strategy and submissions.

· Assess the impact of changes in global regulations on products, processes and procedures.

· Support the development, implementation and management of post-market surveillance processes, and reporting of any device malfunctions and mitigations/remediations.

· Provide regulatory support to the implementation and management of a change control process and assessing regulatory impact on device related changes.

· Oversee the development and management of Clinical Evaluation Plans and Reports.

Education and Experience:

· Bachelors or Graduate degree qualification in Science, Engineering or related field

· 10+ years related experience in medical device/combination product development and regulatory affairs.

· Proven medical device and combination product submission experience in US, EU, UK and other global markets.

· Experience with small molecule/biologic drug development in context of drug/device combination products.

· Knowledge of EU MDR 2017/745, ISO 13485, 21 CFR Part 820 and FDA QSRs is required.

· Knowledge of the relevant regulations and guidelines for inhalation medical devices and combination products is desirable.

· Experience interacting with third party service providers required.

· ISO 13485 Lead Auditor experience desirable.

Knowledge and Abilities:

· Self-motivated with the ability to work in a fast-paced environment.

· Acute attention to detail supported by the ability to see the big picture.

· Creative, flexible, and innovative team player.

· Excellent written and verbal communication skills in English is a must.

· Strong organizational, planning, problem-solving and decision-making skills.

· A self-starter and comfortable working on their own initiative.

· Ability to perform multiple tasks simultaneously and prioritise workload. 

· Maintain a professional and positive attitude and present clear instruction/direction to team members.

· Proven ability to successfully achieve results within a multi-cultural and geographically diverse cross-functional team. 

· Flexible, able to adjust, embrace and drive change. 

· An entrepreneurial, business-oriented mindset and a strong fit with the team and willing to “roll their sleeves up”.

· Resilient, energetic, and enthusiastic. 

· Willing and able to travel

CV’s to Gerry Kennedy at The RFT Group at gerry@rftgroup.ie / 00 353 (0) 1 2302400.