The Regulatory/Clinical Director provides independent regulatory/clinical guidance to product development teams on international pre-marketing applications, and any related submissions to support optimal timelines for new/modified product launches.  This role requires a high degree of flexibility, attention to detail, and good time management. 
 

Responsibilities

• 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 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 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 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 Versono’s regional/country commercial team and distributors, to maintain country specific registrations as needed. 

  
          Job Description: Regulatory Affairs/Clinical Manager                                                       Page 1 of 2
 

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 successfully 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
• Experience in making regulatory submissions valuable
• Good interpersonal & communication skills essential