- 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.
- Prepares IDEs, assists with clinical trials and provides information regarding clinical requirements for international submissions, when require while reviewing clinical trials and providing advice for submissions.
- 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. Also advising engineers and technical experts on regulatory issues.
- Analyses and makes recommendations regarding complaints received by the company 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 labelling, 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 analyses 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
Summary of Minimum Qualifications:
- Education and experience equivalent to a Bachelor’s Degree in the biological, physical, engineering or material science disciplines and 7 years of related experience
- Demonstrated knowledge of global regulatory requirements with emphasis on U.S. FDA regulations, 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
To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E: firstname.lastname@example.org
All applications will be treated with the strictest of confidence. Sigmar will never forward your CV to a third party without prior consent