Regulatory Manager

Role Overview

• Develops and implements global regulatory strategies for Acumed’s orthopedic implants from development through marketing approval
• Provides regulatory leadership and ensures compliance with all regulatory applications including submissions, managing departmental projects, creating, and reviewing labeling, interacting with governmental agencies, and directing and managing department employees
• Understand business needs and implement an aligned strategic plan
• Provides leadership and direction in the creation and implementation of Regulatory policies, procedures, and strategies
• Establishes and executes strategic plan for Regulatory Affairs with executive oversight and approval
• Manages systems for assembly, distribution, storage, tracking and retrieval of information pertinent to the regulatory process, including the FDA regulatory submissions process
• Authors and publishes electronic submissions
• Manages the development of dossiers for registration of products in countries outside the US
• Oversees the authorship and publication of electronic submissions
• Oversees subordinates in the preparation, organization, coordination of content/data and ensures regulatory compliance for submission to the FDA or regulatory agencies
• Assigns Regulatory Specialists to serve on product development teams as core team members and devises and communicates regulatory strategy for new products
• Manages maintenance of required establishment listings for FDA, HC and, EU MDD/MDR including renewal or changes
• Initiates and maintains accurate international product registration, including renewal or changes, and certificates for foreign governments
• Manages correspondence with the regulatory and standards agencies or organizations such as FDA, MDD Notified Body, Health Canada, ISO, Acumed’s EU Authorized Representative
• Helps develop annual operating budget and manages activities to achieve expected budget performance
• Develops and trains staff to ensure appropriate skills/behaviors are present to achieve strategic objectives
• Performs annual performance reviews for direct reports

Requirements

• Bachelor’s degree in life sciences, engineering or related field required
• Master’s degree preferred
• Six to 8 years of experience in a Regulatory Affairs capacity requirement
• Prior leadership/management experience in regulatory environment preferred
• Regulatory Affairs Certification preferred
• Experience in implantable medical device manufacturing required
• Extensive knowledge of cGMP, FDA QSR CFR 820, MDR, ISO 9001, 9002, 13485, CE and other international standards
• Ability to liaise and interact with product development team members with a strong understanding of the product development process
• Ability to manage timelines
• Proven problem-solving skills and the ability to train teams to resolve various issues using available tools
• Extensive knowledge and experience in implementation of Six Sigma quality concepts and techniques
• Familiarity with Lean Manufacturing concepts
• Knowledge and experience with ERP systems and their applications, SAP preferred
• Exceptional organizational skills with extensive knowledge of MS Office (i.e. Excel, Word, Outlook)

Tech Stack

• Assembly
• ERP

Benefits

• Diverse learning and working opportunities
• Culture where everyone’s empowered to be their best
• Competitive annual operating budget management