Job Description
The role involves providing regulatory support for a new product, ensuring compliance with relevant regulations and standards. This includes preparing submissions, conducting risk management reports, and reviewing change control documentation.
* Submission preparation (CE and FDA IDE), including risk management reports, clinical risk evaluations.
* Experience in regulatory submissions, statistical techniques, and FDA inspections.
* Support Design Assurance - Leading the day-to-day regulatory support for a new product.
* Review of change control documentation for potential regulatory submissions.
* Complete all vigilance and post-market related activities.
* 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 the companies 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 companies 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 is maintained or enhanced at all times.
* Lead the writing and review of medical device submissions to be made to the FDA or other Health Authorities for market clearance and assessments of proposed changes to existing products.
* Define the strategy and direct all interactions with the US Food and Drug Administration (FDA) and international regulatory agencies concerning submissions or filings by company to such regulatory agencies.
* 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 company 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 a relevant proven track record, excellent spoken English, a logical, business-aligned approach, and complete commitment to achieving goals.
* The successful candidate will have relevant experience of bringing similar products 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 analyze 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.
* Experience in making regulatory submissions valuable.
* Good interpersonal & communication skills essential.