VP of Quality & Regulatory
Class III Bioresorbable Scaffold : PAD Intervention
Original PMA Submission : QMS Implementation
Hybrid Bay Area : Full Time Direct Hire
Our client is a rapidly growing Bay Area leader in the vascular intervention arena developing a novel 1st of its kind class III sirolimus coating bioresorbable scaffold aimed to improve the standard of treatment for below-the-knee (BTK) peripheral arterial disease (PAD).
This new stent platform is uniquely designed with an ultra-high molecular weight polylactic acid polymer to balance strength and flexibility as a well-needed advancement over traditional metal drug-eluting stents.
This new PAD stent innovation will be a much-welcomed alternative to below-the-knee amputation and could be a highly disruptive concept in a $2.5B+ US PAD market.
Current critical need is toward a new VP of Quality & Regulatory Affairs as a focal point toward all PMA submission activity as well as spearheading company quality management system design and implementation.
This is a mission-critical hire for this growing organization championing their IDE and original PMA as the lead voice with the FDA as well as future international registries.
Our client has just recently raised a substantial tranche of new financing to fund company-wide organizational expansion ensuring this new QA/RA senior leader is well-resourced to complete their mission.
Responsibilities:
- Ability and proven track-record of developing, implementing and executing on PMA, MDR, MDSAP, manufacturing, quality, GDPR and global regulatory/quality procedures to ensure compliance in these areas
- Collaborative leadership style enabling all department teams to excel in their roles and responsibilities to achieve quality and regulatory objectives and do so at a high standard of excellence
- Experience with global regulatory bodies with a track-record of success in meeting those requirements
- Ability to 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 & 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
