POSITION DESCRIPTION:

Responsible for Quality Assurance and Regulatory Compliance for a Medical Device start-up company ensuring that Nervonik meets regulatory and quality compliance as the company develops and eventually commercializes the medical device. Collaborates and provides guidance to R&D, clinical and other functional groups on RA/QA matters and provides leadership for global quality processes. This individual will ensure design control requirements and necessary QMS Systems, appropriate for the level of product development, are implemented and followed.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Leads the Quality effort during the development of next generation ablation catheter and generator platform.

• Effectively works with R&D, Development, Supply Chain, Production and Facilities to ensure quality and regulatory objectives are met throughout the Product Realization lifecycle.

• Creates and reinforces a culture of teamwork and actively resolves conflicts within the team.

• Assists in preparation of U.S. FDA PMA and/or 510(k) and global regulatory submissions for new and current products as required. Ensures that all submissions are accurate, completed in a timely manner and meet regulatory standards.

• Knows and understands the regulatory environment in which Nervonik operates (Medical Device) and ensures that Nervonik’s quality system complies with regulatory and quality requirements including ISO 13485 and 21CFR Part 820 as well as IEC62304, IEC62366 and IEC60601.

• Develops and executes new product development quality strategies and establishes product performance goals for the quality organization.

• Ensures effective execution of the quality management system in support of new product development, IDE and commercialization.

• Continuously improves quality processes and quality systems with the goal of improving patient outcomes, reducing risk, maintaining regulatory compliance, and improving product quality/reliability.

• Leads the relationship with customer and external auditors on quality and regulatory compliance issues.

• Reviews product labeling and marketing materials to ensure compliance with quality and regulatory requirements.

• Provides guidance, interpretation, and opinions on changing worldwide regulations, while maintaining active involvement in medical device quality and regulatory affairs organizations to ensure up-to-date knowledge of current and future industry trends.

• Ensures all employees maintain training records that comply with applicable quality system requirements.

• Applies and mentors/coaches the application of technical principles, theories, concepts and quality tools to complex systems and processes.

• Tracks and monitors internal process nonconformities, deviations, complaints/feedbacks, and CAPAs to drive closure.

• Deploys excellent project management skills to develop quality objectives, manage overall quality plans, corrective and preventative actions, process improvement, and auditing timelines.

• Leads preparations for internal and external Quality Management Systems audits, including regulatory bodies and clients.

• Works closely with Purchasing / Supply Chain to maintain the ASL and establish supplier quality requirements, quality metrics and corrective actions for all external suppliers.

• Solves problems using established analysis techniques such as FMEAs, Fishbone Diagrams, 5 Why’s analysis, or other standard problem-solving tools consistent with a six-sigma mindset as needed.

• Manages and maintains the company’s quality inspection and product release programs for incoming and in-process materials and components, processes and finished goods.

• Prepares quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, recalls, corrective actions, and re-validations.

• Other duties as assigned by management.

EXPERIENCE & QUALIFICATIONS:

• 15 or more years’ experience in a medical device

• Minimum of 8 years of Regulatory Affairs supervisory experience.

• Minimum of 15 years of people management experience.

• Strong knowledge of FDA, EU, Health Canada and other applicable international regulatory requirements including clinical trial requirements, quality system requirements, submission requirements, labeling and promotion requirements.

• Excellent organizational, computing and verbal/written communication skills.

• Highly skilled in delivering and driving Change Management for teams and organizations.

• Strategic and analytical skills.

• Project management leadership experience.

• Strong critical thinking and decision-making skills.

• Ability to work well independently or within a cross-functional team environment.

• Knowledge of cGMP regulations ISO 13485, 21CFR Part 820, CMDR SOR/98-282, 93/42/EEC, RDC 16 2013, MHLW MO 169 and TG(MD)R Sch3 preferred.

Interesting applications should send their resume to hr@nervonik.com