.direct message the job poster from goseco international executive searchgoseco international executive search has been exclusively retained on behalf of one of our global clients to conduct the search for their manager of regulatory and compliance in guadalajara, jalisco, mexico.company overviewour client is an international leader in 7+ countries across three continents in advanced manufacturing and product development across highly regulated industries, including medical devices, aerospace, and high-tech electronics.
from olympic stadiums to surgical suites, their products power some of the most mission-critical applications on earth.position summarythe manager of regulatory and compliance will play a pivotal leadership role in ensuring regulatory excellence and inspection readiness at one of their most strategic sites worldwide.this is your opportunity to step into a high-impact leadership role at a global technology company that's shaping the future of advanced electronics and medical device manufacturing, take the reins of a mature compliance function, and elevate it even further, driving excellence in both global regulatory frameworks and hands-on validation processes.essential duties & responsibilitiesvalidation process:responsible for maintaining the validation program in an audit-ready state and in accordance with current regulations and in alignment with the company's procedures.may act as a local subject matter expert / trainer for process validation to the team involved in process validation.
may act also as subject matter expert for internal or external customers.mentor and support staff by providing training and technical guidance in decision making, determining validation strategy.reviews and approves validation plans, protocols, and reports.support product transfers/new product development.
ensure integration of validation schedule in production schedule for implementation of validation activities.regulatory:primary contact and resource during fda inspections; conducts regulatory activities and interacts with fda and/or other regulatory agencies to ensure compliance.researches, identifies and keeps updated on outside medical regulations, update processes where necessary, and communicates requirements, updates/changes affecting the quality system to concerned parties.identifies and coordinates the submission of all pertinent information for new medical device product approval and monitors the regulatory status of new product developments.maintains compliance of process and system procedures to fda/qsr requirements and analyzes audit and performance results to identify deficiencies and improvement opportunities.regulatory designate for review and approval of all applicable regulated device documentation.review and approval of regulated devices frameworks.verifies medical device manufacturing per the medical devices regulations.approves validations for manufacturing of regulated devices