The Senior Regulatory Affairs Specialist is responsible for assisting in the preparation of regulatory submissions ensuring all documentation meets world-wide requirements and for facilitating company business objectives within set timelines. Key duties include strategic planning, coordination, writing and preparation of regulatory and technical documents for global investigational and marketing applications for medical devices.
Essential Job Functions:
Acts as a core member on development teams to provide regulatory guidance and develop regulatory strategies and timelines;
Prepares documents necessary for new product market clearance, approval and continuance during product life cycle management that includes (but is not limited to) 510(k)s, supplements, pre-IDEs, technical files and design dossiers for CE marking
Prepares and/or compiles information required by OUS Tornier subsidiaries or distributors to support international regulatory body product approval/ licensing;
Interacts with global regulatory bodies;
Interacts with Research and Development, Marketing, Clinical Research and other cross-functional departments to ensure coordination of information to meet regulatory requirements;
Develops post-market strategies, provides support and ensures compliance of market released products;
Maintains Tornier’s US FDA and US State facility registrations;
Maintains Tornier’s US developed product country product listings;
Monitors proposed and current global regulations and guidance and advise on impact of such regulations and guidance on the company;
Reviews and approves change orders;
Serves as an internal consultant on regulatory issues such as recalls, field actions, labels, labeling and advertising and promotional activities.
Skills, Abilities and Education Requirements:
B.S. in a scientific discipline
Minimum of 8-10 years regulatory affairs experience
Must be able to write clear, understandable technical documents, i.e. regulatory documentation or scientific presentations
Ability to compile data and summarize results
Current knowledge of FDA medical device regulations, EU Medical Device Directive, Health Canada and Australia regulatory requirements
Current knowledge of FDA quality system, Good Clinical Practice and recall requirements; and ISO 13485:2003 quality systems for medical devices,
Strong communications skills (in English), leadership, ability to work with cross functional groups, and multidisciplinary experience is preferred.
Must be self-motivated with an ability to work with minimal supervision, have interest in leadership and a demonstrated ability to achieve results via coordination with teams of professionals.
Ability to travel up to 20%.