VP Global Quality and Regulatory

VP Global Quality and Regulatory

Trelleborg Medical Solutions is seeking a VP Global Quality and Regulatory, based from their Minneapolis MN headquarters.

As a valued team member with Trelleborg, you will enjoy:

• Competitive compensation: $220,000-225,000 + bonus opportunities!
• Generous benefits package: Includes health, dental, vision, STD, LTD, life, 401k, paid time off, tuition reimbursement, and more!
• Clean work environment: Enjoy working in a very clean and climate-controlled environment every day!
• Greater opportunity for impact: You will have the autonomy and support to lead the production team and impact the production of life-saving devices.
• Growth and advancement: Join a global company that loves to promote from within and allows for advancement into one of their many other U.S. locations!

This position is a strategic business partner to the BA President in managing Global Regulatory and Quality functions throughout the BA.

This position drives the strategy for the BA to comply with the requirements of the global landscape for class I, II & III productions, in a cost effective and pragmatic manner. The position takes a holistic approach to include manufacturing, services and 3rd party purchase for resale products into scope, and other business models as the business develops. Stressing global in approach, inclusive of sales and logistic centers.

Tasks and Responsibilities:

• Aligns the quality strategy to fulfill the business area strategy.
• Owns global Quality and Regulatory budget and cost-of-quality performance
• Drive quality as a competitive advantage enabling growth and commercial success
• Defines and tracks KPI's aligned to business outcomes
• Champion of global culture of quality, accountability and continuous improvement
• Deploys Lean/Six Sigma or equivalent methodologies across the organization
• Lead implementation and optimization of eQMS and digital regulatory tools
• Utilizes data analytics and predictive insights to proactively manage quality risks
• Owns strategy with corporate objectives and manage product registrations in existing and emerging markets. Inclusive of material regulatory.
• Represents the company with regulators, industry bodies and external stakeholders

Oversees the remainder with delegation to their team:

• Oversee FDA listings, EU conformity declarations, etc., to ensure clearance to distribute products.
• Oversee product listings, declarations and regulatory approvals (ie 510(k), ISO, CE, CMDCAS) are submitted in accordance with all applicable regulations and are kept up to date. Responsibilities include: determining the type of listing, registration, and/or approval needed (by country); classifying the device appropriately per 21CFR, CE, CMDR, etc.; preparing & filing listings, 510(k)'s, Declarations of Conformity, etc. to all applicable countries.
• Oversee the Vigilance/Medical Device Reporting System including preparing and submitting reports and maintaining records/files of incidents including any remedial actions taken. Coordinate Recall & Field Action situations to comply with US & international regulations and company policies/procedures.
• Responsible for assuring products, labeling/packaging and advertising are in compliance with all applicable regulations.
• Coordinate FDA/EU or any other country required inspections and audits, respond to findings and maintain records of all activities. Assure that any product detentions are promptly resolved; provide interface with FDA field offices as needed.

Education and Experience:

• 15 years plus of experience in a global organization within a regulatory or quality function
• Minimum of 4 Year College degree in a technical field
• Masters is plus
• Ability to work in a fast paced, global environment with matrix organization

Competencies:

• American Society for Quality (ASQ) certification and/or Regulatory Affairs Certification (RAC) preferred
• Core competency as demonstrated by previous compliance responsibility for ISO 13485 and 14971; MDD; MDR; FDA cGMPs; FDA QSRs; UL; CE; and IEC Standards
• Subject Expert in US FDA Regulations, Standards, Documentation, Labeling
• Knowledge of laws, legal codes, court procedures, precedents, government regulations, executive orders, agency rules, and the democratic political process
• Knowledge of 21 CFR 801, 803, 806, 807, 820
• Knowledge of FDA guidelines and ISO standards for Medical Devices
• Knowledge in IEC 60601-1 and foreign regulations for medical devices
• Working knowledge of Medical Device Regulations, Quality Systems Regulations, and other US and Intl regulations and standards that apply to the Class II and Class I medical device industry
• Working knowledge of and ability to assist in the creation/review of technical sections in support of regulatory submissions for assigned projects including 510(k) and device combination products.
• Knowledge of FDA and FTC labeling, MSDS standards, CPSC, and EPA requirements
• Knowledge of technical standards and GMP

Travel requirements as needed by the BA to fulfill the obligations of the position

About the Company:

Trelleborg Medical Solutions partners with the world's leading medical device and biopharmaceutical companies, collaborating from concept to commercialization to bring to market impactful solutions that improve patient quality of life. It leverages decades of design and manufacturing experience, in-depth knowledge of polymer materials and a deep understanding of customer applications and end-use environments to deliver pioneering, engineered solutions for transformative health technologies. Utilizing its global quality system and engineering and manufacturing network, the company is a production partner of choice for medical devices and biopharmaceutical companies.

All qualified applicants will receive consideration for employment without regard to the individual's race, color, sex, national origin, religion, age, disability, genetic information, status as a military veteran or any other characteristic protected by applicable law.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.