Manager, Regulatory Affairs coordinating global regulatory submissions for therapeutic development. Collaborating cross - functionally to meet regulatory agency requirements and ensure compliance.
About the role
- Regulatory Manager responsible for developing global strategies for orthopedic implants at Acumed. Ensures compliance with regulatory applications and directs departmental projects.
Responsibilities
- 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)
Benefits
- Diverse learning and working opportunities
- Culture where everyone’s empowered to be their best
- Competitive annual operating budget management
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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