Regulatory Affairs Strategist/ RA Project Manager
Job ID: JOB-13189
Regulatory Affairs Strategist/ RA Project Manager
We are looking for a RA Strategist to join the growing RA team of our client in Wexford. In this role the RA Strategist will be working with the latest technologies across a broad portfolio of products which includes PTA balloon catheters, stent grafts and active devices. This is a highly visible role within the organization, and you will work in cross-functional teams as the regulatory medical device expert (e.g. sustaining engineering projects, new product development projects, MDR compliance program, etc.).
- Ensures compliance with applicable Regulatory Requirements for all applicable territories in which devices are placed on the market.
- Inputs to development of regulatory strategies and provides regulatory guidance and expertise.
- Compiles and communicates regulatory requirements (e.g. MDR, FDA, International, standards, etc) to support R&D, Manufacturing & Quality to ensure systems are compliant with all internal and external guidelines.
- Prepares and presents gap analysis assessments of regulations and guidance’s to peers and cross-functional groups in a concise and precise manner.
- Reviews and approves the project documentation (design reports, labelling, etc.).
- Develops tactics supporting regulatory notifications and submissions to minimize the market supply impact as a result of device changes.
- Participates in product development/sustaining teams as required to ensure that the product is in compliance with all internal and external regulatory requirements.
- Preparation and submission of dossiers to regulatory authorities for CE mark and FDA approval
- Regulatory assessments of change requests and impact on global registrations
- Provide support for regulatory authority and customer audits
- Understand and follow company procedures on regulatory requirements.
- Provide positive example and actively promote compliance to all standards.
- Maintain a professional working relationship with internal and external customer and support staff.
- Prepare and present project updates and technical discussions.
- Required to travel to EU & USA for meetings.
Education and Experience
- Minimum of degree in Life Sciences or Engineering or equivalent
- Minimum of 5 – 7 years’ experience in a similar position in the medical device / pharmaceutical industry.
- Have worked with regulatory submissions with exposure to implantable devices.
- Knowledge and experience on EU MDR and standards (ISO 13485, ISO 14971) is a must, knowledge of FDA and international regulatory requirements is a plus
Knowledge and Skills
- Regulatory Affairs / Quality Systems experience in the Medical Device or pharmaceutical industry
- Good regulatory knowledge, e.g. guidelines, policies, principles and requirements of applicable product laws/standards
- Knowledge in CE marking according to MDR
- Good knowledge in labelling requirements and procedures.
- Ability for strong attention to detail in a complex work environment with multiple and competing registration priorities
- Project management skills with good planning and organizational skills
- Basic analytical and problem-solving skills
- Basic Project Management Experience preferable
- Strong team player within RA team, other functions and international colleagues
- Excellent English communication skills are a must.
- The successful candidate will have solid educational background with a degree in Science or Engineering or relevant scientific discipline with work experience in Regulatory Affairs and/or Quality Systems, preferably in the Medical Device or Pharmaceutical industry. You will have good regulatory knowledge, e.g. guidelines, policies, principles and requirements of applicable product laws/standards.
- You will have the ability for strong attention to detail in a complex work environment with multiple and competing registration priorities. Good planning and organizational skills. German knowledge is an advantage.
For further information on this role in Wexford please contact Aisling Kidney on 0872197421 or firstname.lastname@example.org
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