Are you looking to join a growing R&D Medical Device Start Up based here in Galway? This company is going through its third year of growth. If you are looking for a role with an opportunity to make a real impact and also have purpose and exposure to the wider business. please get in touch today to discuss this role.
The Senior Regulatory/Clinical Specialist provides independent regulatory/clinical guidance to product development teams on international pre-marketing applications. This role requires a high degree of flexibility, attention to detail, and good time management. This will be a hybrid role organising your work patterns from home and the office.
- Define the regulatory strategies, for our clients devices within the product development process, with input/direction from the senior leadership team and Design Assurance
- Experience in regulatory submissions, statistical techniques, and FDA inspections.
- Lead the preparation/writing of 510 (K) regulatory filings and FDA correspondences to support submissions.
- Support Design Assurance in the day-to-day regulatory support for a new product.
- Review of change control documentation for potential regulatory submissions.
- Responsible for Regulatory Compliance (PRRC) as per Article 15 of MDR 2017/745.
- Identifies and plans regulatory and clinical activities including continuous improvement initiatives that support our clients Medical Device(s).
- Effectively represents the company in collaborations with investigators, KOL’s, CRO’s and clinical hospital staff.
- Drives and supports clinical publications: work closely with PI’s and KOL’s to define study protocols, select study sites, drive and control execution, collect and analyze data, support PI in writing up and publish study results
- Responsible for ensuring all activity in this area meets our clients business ethics responsibilities.
- Formulate, implement, maintain, and control RA/Clinical policies and procedures to ensure that full regulatory compliance with FDA, other Health authorities and standard protocols.
- Oversee and direct the processes for the creation and review of product labelling, packaging, promotional materials, etc.
- Support the planning of product development and commercialization projects. Organizes and prioritizes assignments for the RA/CA tasks.
- Read, review, interpret and keep current with local, regional, and national regulations and publications regarding medical devices.
- Interact with representatives of domestic and international partner companies and international regulatory authorities as needed to discuss regulatory issues and submission requirements.
- Work with our clients regional/country commercial team and distributors, to maintain country specific registrations as needed.
Knowledge and skills required
- Degree in Clinical, Regulatory or Science discipline
- 5+ years’ experience in Regulatory Affairs and/or Clinical Affairs roles desirable.
- The successful candidate will have, excellent spoken English, a logical, business aligned approach, and complete commitment to achieving goals.
- The successful candidate will have relevant experience of bringing similar product to market.
- Current understanding of FDA and ISO requirements, with the ability to translate these requirements and implement them into the Quality system.
- Strong Technical aptitude with an ability to analyse and challenge technical data, identify and address gaps, and generate technical reports to support submissions.
- Clear writing skills and comprehension skills.
- Experience in dealing with regulators and leading external agency inspections an advantage
- Good interpersonal & communication skills essential.
For more information and a confidential discussion on the role and the company please contact Chris O Toole