To obtain and maintain regulatory approval and license in the global market for our diagnostic products and systems and thereby guarantee continued sales eligibility, we are looking to strengthen our R&D team with a Regulatory Affairs Manager.
In taking up this job you are responsible for the management of the registration and labelling strategy of our newly developed and established diagnostic products.
Your key tasks will be to:
- ensure world-wide licenses in line with applicable regulations for all existing and new products/systems;
- evaluate the regulatory environment and asses impact on new and existing regulatory files;
- provide guidance and advise to the organization regarding regulatory requirements;
- establish and maintain an ongoing dialogue with health authorities, notified bodies and other regulatory institutions;
- act as regulatory representative during internal and external audits;
- ensure the creation and adaptation of product labels, packaging and product master information in line with applicable internal procedures and external regulations;
- lead and coach the regulatory and labelling team members;
- ensure accurate and timely adverse event reporting to competent authorities.