Our clients products and technologies are used to diagnose or treat a wide range of medical conditions, including heart, digestive, pulmonary, vascular, urological, women’s health, and chronic pain conditions. We continue to innovate in these areas and are extending our innovations into new geographies and high-growth adjacency markets.
Our journey of innovation began in 1979, when our revolutionary steerable catheters were first used in less-invasive procedures. Today, we continue our legacy of delivering meaningful innovation to meet patient needs around the world and deliver economic value to our customers.
Responsible for Regulatory Affairs support of the product development process, submissions and regulatory compliance.
Is an effective team leader, fully motivated to achieve and demonstrate best practices in line with the goals of the regulatory department.
Interfaces with manufacturing, engineering, R&D and quality representatives to provide consultation on the impact of proposed changes to product, processes and the quality system.
Act as a team member in product development programmes and demonstrates a good understanding of the PDP process.
Maintains and enhances cross-functional team relationships.
Review applicable Corporate SOP’s for effect on local regulatory processes and systems.
Preparte and maintain Technical Files and Design Dossiers.
Preparte and maintain FDA submissions including IDEs, 510k’s and PMAs.
Review and approve documentation related to product release.
Provide input, review and approve artwork for labeling and DFU’s
Participate in Regulatory body audits, such as FDA, Notified Bodies, Compentent Authorities and other global regulatory agencies.
Liase and provide support to international regulatory colleagues.
Demonstrate and actively promote highest level of professional regulatory discipline.
Liases with both middle and senior management on any regulatory issues relating to their area.
Skills, Experience & Qualifications:
Bachelor’s degree (HETAC level 8) and minimum 5 years relevant work experience.
Possesses excellent communication skills
Demonstrated track record in Regulatory Affairs
Ability to work with minimum supervision and in a fast paced environment
Excellent interpersonal and stakeholder management skills