- Provide strategic operational insight and knowledge as a key member of the Supply Chain Operations team. Work under direction of the CSCO to ensure alignment of the Quality and Regulatory Affairs strategy with the overall company strategy. Requires capability of planning and executing to the Quality & Regulatory Affairs strategy with aggressive, but reasonable, goals and milestones.
- Function as the Official Correspondent/ Responsible Authority for all Joerns sites and the designated signatory for all regulatory agency interaction(s) for the FDA, Health Canada, and NHS systems.
- Implement Quality & Regulatory Affairs systems, processes and controls to constantly monitor and ensure the quality, safety, regulatory compliance and continuous improvement of Joerns global product and services portfolio.
- Drive quality and regulatory affairs improvements and compliance throughout the entire organization from design to delivery of Joerns products and services.
- Develop and lead a strong quality & regulatory affairs team across the Joerns platform, providing effective leadership, support, training, and mentorship to Joerns quality & regulatory affairs organization.
- Identify and implement opportunities to develop alternative quality and regulatory affairs solutions that lead to the continual reduction of the cost of quality.
- Establish effective relationships cross-functionally across the company to integrate quality and regulatory affairs activities with the overall company goals, plans, and objectives. Supporting the CSCO, upgrade quality & regulatory affairs management to better coordinate the global quality management vision across manufacturing, supply chain, and commercial services.
- Lead and direct the Regulatory Affairs function for Joerns insuring that mandated aspects are complied with and interface and coordinate with legal affairs related to product claims (lawsuits), subpoenas, depositions, exploratory calls and site visits by the Joerns legal team and/or legal partners.
- Act as final signatory approval for all design control related documentation, technical file/CE Mark Declaration-of-Conformity, product and marketing literature, ISO documentation, product drawings and document change orders.
- Act as final release authority for all newly developed or transitioned company product(s) ensuring all regulatory requirements have been met.
- Develop and implement quality programs and strategies that enhance the organization’s quality assurance effectiveness, lower operating costs, and improve overall quality and product safety.
- Develop and implement regulatory affairs systems and strategies that ensure compliance with all applicable regulatory guidelines and agency statutes and assure Joerns products and services remain compliant, registered, and approved for use.
- Build strong relationships with internal and external customers to build, enhance, and ensure quality awareness and regulatory compliance.
- Lead all monitoring of required site processes and competencies to ensure that quality standards are implemented in accordance with corporate goals.
- Ensures the proper interface of the quality function to product development, manufacturing, supply chain, and other areas as required.
- Provides overall supervision of Joerns Quality & Regulatory Affairs staff inclusive of Service Operations Quality, Site Quality Manager(s), Supplier Quality Engineering, Document Control, Quality/Regulatory Affairs, Continuous Improvement, and Failure Investigation.
Bachelor’s degree (B.S.) in science, math or engineering discipline.
Required Skills & Experience
- 7+ years of progressive quality and regulatory affairs leadership experience in a FDA regulated medical device environment, including 5+ years of managing others.
- Relevant certification(s) from recognized organizations such as ASQ (American Society for Quality), Global Regulatory Affairs Compliance Professional (GRACP) is a plus.
- Lean and 6 Sigma certifications a plus.
- Ability to travel up to 25% of the time.
- English fluency; multilingual preferred (concentration in Spanish or German).
- audiences of various sizes. As a representative of Joerns, professional demeanor is required at all times with internal and external interactions.
- Must have a track record of success and a broad understanding of contemporary quality practices as they apply to product development, manufacturing and commercial operations in a FDA regulated and ISO certified environment.
- Has an advanced understanding of Quality and Regulatory Affairs requirements globally, specifically knowledge of current FDA, EPA, ISO, Health Canada, and NHS guidelines.
- Experience in development of an organizational culture that promotes and sustains quality as an element of superior business performance.
- Extensive relevant experienceapplying Quality risk management for medical device product development and manufacturing.
- Proven history of building strong collaborative relationships with regulatory agencies.
- Experience with all phases of the product development lifecycle, including concept, design, implementation, verification and validation activities necessary for product commercialization.
- Extensive experience in GMP and other Regulatory compliance requirements.
- Experienced in regulatory filings for US, EU and other key countries/regions.
- Experience working in a lean/kaizen culture, with a track record of utilizing these methodologies as a competitive advantage.
- Proven ability to develop people and instill a commitment to excellence throughout the organization. The capability to motivate employees to a high degree of performance, being a good listener with outstanding people skills, and possessing a high sense of personal values and integrity are essential.
- Experience/training benchmarking all areas of quality assurance and regulatory affairs.
- Excellent written and verbal communication skills, including the ability to successfully communicate with suppliers, customers and across staff levels.
- Develop and be accountable for the assigned budget. Manage within corporate parameters including total limits, phasing of spend, potential adjustments due to business needs communicated by the CSCO.
Preferred Skills, Experience & Education
- Master’s degreepreferred.
- English fluency; multilingual in German, Dutch or Spanish is preferred.