Regulatory Affairs Associate Director

Minimum bachelor’s degree in a technical field (e.g., engineering, biology, chemistry, pharmacy). Advanced degree preferred; medical training preferred.
Minimum 8 years of regulatory affairs experience within the pharmaceutical or medical device industries, ideally with expertise in drug-device combination products; experience in regulatory and/or R&D, quality engineering functions, strong knowledge in design control and product development, and multiple submission dossier preparation and interaction with regulatory authorities is required.
Demonstrated supervisory and leadership skills; able to drive change and inspire associates.
Ability to navigate in a matrix environment and build solid relationships enabling RA to be a business partner and a strong and respected voice.
Comprehensive knowledge of U.S. medical device regulations (FDA), Clinical Practice standards, Laboratory Practice regulations, and Quality System Regulations.

Lead team ensuring the right balance between support and empowerment as well as the right level of development and coaching to support cultural change and position RA team as solution providers.
Own regulatory strategy to ensure all Pharmaceutical Systems (PS) products meet the latest regulatory requirements to ensure new product developments is successful.
Own promotional material review activities and business specific procedures; accountable for alignment of external communication and claims to regulatory requirements.
Educate and train PS cross-functional teams on EU and FDA requirements applicable both to pharmaceutical systems and our customers, on an ongoing basis, to ensure regulatory framework understanding.
Accountable for appropriate registrations with the Competent Authorities as well as regular updates; develop response strategies for regulatory questions and prepare team for interacting and negotiating with regulatory agencies if necessary.