VP of Quality and Regulatory Affairs

4 weeks ago

California, United States The Mullings Group Full time

Job Summary

The Mullings Group is seeking a highly experienced VP of Quality and Regulatory Affairs to lead our client's quality and regulatory efforts in the development and commercialization of a novel Class III bioresorbable scaffold for peripheral arterial disease (PAD) treatment.

Key Responsibilities

  • Develop, implement, and execute on PMA, MDR, MDSAP, manufacturing, quality, GDPR, and global regulatory/quality procedures to ensure compliance in these areas
  • Collaborate with cross-functional teams to achieve quality and regulatory objectives and maintain a high standard of excellence
  • Experience with global regulatory bodies and a track-record of success in meeting those requirements
  • Develop, articulate, and execute on global regulatory and quality strategies
  • PMA experience with stents, drug-eluting/device combination products, catheter, and balloon systems with direct understanding of manufacturing and quality system requirements and testing requirements to achieve a successful PMA approval
  • Experienced with a modular PMA approach
  • FDA PMA and 510(k), MDR, PMDA, and global regulatory interaction and understanding of these approval/clearance processes
  • Track-record of achieving IDE approvals and partnering with clinical, R&D, and manufacturing teams to ensure a successful trial outcome
  • Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to project teams, and provides input related to FDA and international product registrations and licensing requirements
  • Establishes and executes regulatory strategy in partnership with leadership, product, and clinical teams
  • Prepares, reviews, approves, and submits Pre-Market Approval documents as well as 510(k)s, IDEs, HUDs, etc. Prepares and submits PMA and IDE Submissions and Supplements
  • Works with international affiliates to compile and submit international product registrations and licensing applications
  • Interprets new or existing regulatory requirements as they relate to the product portfolio and regulatory and quality system procedures
  • Reviews and advises on labeling, product claims, marketing brochures, and other publications to ensure compliance with regulations
  • Maintains annual licenses, registrations, and listing information
  • Assists with compliance to product post-marketing approval requirements
  • Supports all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
  • Reviews protocols and reports to support regulatory submissions
  • Acts as liaison between the Company and the various regulatory agencies
  • Interfaces directly with FDA and Notified Bodies. EU, APAC, North America.
  • Reviewing product design and manufacturing changes to assess regulatory impact and completing any associated regulatory activities
  • Maintaining knowledge of rules and regulations of federal entities in the U.S. and overseas such as: U.S. Food & Drug Administration (FDA); Japan Pharmaceutical Manufacturers Association (JPMA); China Food and Drug Administration (CFDA); European Medicines Agency (EMA), etc
  • Interfacing with external Quality Auditors and Regulatory Agencies and maintaining regulatory files
  • Ensuring Class III medical devices will achieve PMA approval with national and international regulators
  • Interviewing, hiring, training, and developing subordinate staff

Qualifications

  • Ability to identify critical path activities and articulate and mitigate risks to clinical trial conduct
  • Strong working knowledge of FDA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials
  • Experience in Class 3 implantable devices, peripheral vascular, or cardiovascular implants preferred
  • Strong communication skills, both verbal and writing
  • Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute on goals as a member of an interdisciplinary team is extremely important
  • Highly collaborative and comfortable in a hybrid work environment
  • BS/MS Degree in a scientific discipline with a minimum of 10 years of regulatory experience in the medical device industry
  • Experience in breakthrough designation a plus
  • Some travel expected

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