Principal Regulatory Affairs Specialist Ireland
What is the vacancy about
- Determines global regulatory pathways for various projects for EU, US and International product launches / product enhancements
- Identifies guidance documents, international standards, consensus standards and assists teams with their interpretation.
- Prepares regulatory submissions to regulatory authorities and/or distributors (including the FDA, Notified Bodies, Health Canada and other regulatory authorities).
- Works with engineers and technical experts to resolve potential regulatory issues and questions from Regulatory Agencies
- Interacts directly with international regulatory agencies on products / projects at reviewer level and elevates significant issues to management
- Prepares IDEs, assists with clinical trials and provides information in regard to clinical requirements for international submissions, when required.
- Reviews significant product and clinical study submissions with management and negotiate submission issues with agency personnel
- Interacts with various levels of management, external agencies and companies.
- Analyzes and makes recommendations regarding complaints and whether they are MDR, MPR or Vigilance reportable in markets; participates in complaint related meetings.
- Provides support for commercialized products as necessary by reviewing labeling, promotional materials, and product and documentation changes per policy and procedure
- Assists with departmental policy implementation
- Maintains and enhances cross-functional team relationships
- Provides technical guidance and regulatory training / mentoring to other Regulatory Affairs employees and cross-functional teams
- Develops, maintains and analyzes department systems and provides training when needed.
- Maintains expertise in worldwide regulatory requirements; establishes and maintains positive relationships with regulators
- Participates in and assists with FDA facility inspections, Notified Body Audits and other governmental inspections as directed.
- Performs other related duties and tasks, as required.
- Education and experience equivalent to a Bachelor’s Degree in the biological, physical, engineering or material science disciplines and a minimum of 5 years of related experience.
- Demonstrated knowledge of global regulatory requirements with particular emphasis on U.S. FDA regulations or EU Regulations and various Quality System Standards/Regulations/Laws, including but not limited to ISO 13485, etc
- Must have experience working with regulatory agencies and submission reviewers
- Self-motivated, self-directing, strong attention to detail and excellent time management skills.
- Strong interpersonal skills and the ability to communicate well – verbally and in writing – with others
- Excellent analytical and problem-solving skills
- Demonstrated excellence in submission writing and preparation
- Demonstrated computer skills preferably spread sheets, word processing, database, internet research and other applicable software programs.