Director of Regulatory Affairs and Quality – Relocation offered
- San Antonio, San Antonio, TX, us
Growing San Antonio based Company with a phenomenal reputation of being people centric and for giving back to the community. The Company is well known for its track record of internal promotion and career development. Offers great benefits and several weeks of vacation! Culture is open of team work and collaboration with great work life balance.
Come join the team to lead Global Regulatory Strategy for the business product platforms and new products. This position works closely with the business to create and deliver on regulatory strategies that enable the goals of the business to be met while assuring compliance to regulations. This position also works with the sustaining engineering functions to support post market changes to product platforms.
- Provides regulatory support and guidance to assigned business franchise to enable the timely commercialization of new products and product updates.
- Architects the overarching regulatory strategies for the product platforms. Develops a regulatory strategy for each new product development project to facilitate timely commercialization and globalization.
- Interprets regulations to develop solutions to regulatory challenges in order to satisfy business needs while ensuring compliance to regulations.
- Prepares regulatory submissions to obtain clearance by the FDA. Develops requirements for content of technical protocols, reports, and summaries used in support of the submissions.
- Provides guidance and advice to new product development teams on design development to ensure project activities are in alignment with the planned regulatory strategy.
- Reviews and approves product labeling.
- Works with the Regulatory Affairs Project Management to create project schedules to plan the execution and timing of regulatory activities.
- Reviews and approves promotional and advertising materials as well as medical education training, literature, and copy materials to assure compliance with cleared/approved labeling and marketing requirements. Recommends alternate language, as appropriate, to ensure acceptable regulatory alternatives.
- Assesses design, labeling, and manufacturing changes to products and determines impact to regulatory filings. Advises project teams on regulatory approach for changes and prepares submissions or letter to file documentation as required.
- Maintains current knowledge of FDA and international regulations, and standards applicable to company products.
Skills and Experiences:
- Bachelors degree
- Ten (10) plus years’ experience working in the medical device, pharm or highly regulated industry
- Experience working with new product development teams, and substantial knowledge of Design Controls.
- Experience analyzing technical and scientific data and reports.
- Experience reviewing promotional and advertising materials.
- Knowledge of and experience with FDA.
- Knowledge of enterprise application integration techniques a plus
- Experience with FDA software verification and validation requirements a plus
- Knowledge of global medical device regulations and standards
- Experience working in International Regulatory Affairs a plus
- Regulatory Affairs Certification (RAC) a plus
$180,000 - $195,000 + 25% bonus, great benefits, several weeks of vacation