תיאור המשרה | Essential Roles and Responsibilities:
• Provide regulatory strategic direction on projects/products.
• Identify and assess regulatory risks and project/product issues as well as recommend solutions and strategies to teams and management.
• Conduct and analyze regulatory research providing guidance to teams on past precedence, competitive landscape, and recommended regulatory pathways.
• Effectively manage R&D project timelines as defined by department, project team, and corporate objectives
• Lead major submission activities.
• Plan and prepare regulatory submissions (510ks, Post Marketing reports) for new and existing medical device products to ensure the timely approval for non-clinical studies and marketing applications.
• Ensure documents are in compliance with current regulations and guidance.
• Maintenance of establishment registrations and listings
• Provide regulatory input to Quality and Operations functions for post-market project activity, including change control assessments.
• Review product labeling for regulatory compliance.
• Primary point of contact for regulatory requirements to internal stakeholders.
• Interact with contract manufacturers, affiliates and distributors.
• Maintain current regulatory knowledge of regulations, guidelines, and standards and apply appropriate implementation strategies.
• Manage 2 employees.
• Professionally supervise RA representatives all over the world (currently 3 locations not including IL).
Knowledge and Skills
• Hands on Experience with preparation of Technical Files and Post Marketing reports.
• Experience with regulatory/compliance in non-clinical, manufacturing issues.
• Good working knowledge of regulations for medical devices: 21 CFR 820, ISO 13485 (2016), CMDCAS, ANVISA, MDD & CE marking.
• Demonstrated organizational skills, ability to independently prioritize work and detail oriented.
• Strong verbal and written communication skills in English.
Education
• Bachelors or better.
Experience
• Strong knowledge of US Class 2 medical device regulatory environment and 21 CFR 820, ISO 13485 (2016), CMDCAS, ANVISA, MDD & CE marking.
• 4 years: Relevant regulatory experience
|
