Direct message the job poster from goseco international executive search
goseco 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 overview
our 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 summary
the 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 & responsibilities
validation 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.
* approves change control of documents related to the manufacturing of regulated devices.
* review and consult on new and ongoing projects for regulated products to ensure the schedule and regulatory decisions made are compliant to fda and customer requirements.
* review and approve corrective and preventive actions from audits and customer complaints related to regulated devices utilizing strong problem-solving skills, resulting in effective, compliant actions. Provided training on problem solving techniques and tools for cross functional groups.
* reviews and authorizes disposition of nonconforming materials for regulated devices.
* assess and approve any change to process, documentation, equipment, etc., in order to confirm no impact to validated state.
* plans, schedules, directs, evaluates, and manages the work assignments to meet the department goals in terms of quality, productivity and efficiency. Also develops, implements and maintains resource planning tools in order to project staffing needs and manage cost.
* leads the inspection readiness core team: audit and inspection preparation and response activities.
* serve as a regulatory advisor and subject matter expert to operational areas and the compliance team.
* oversee and participate in the preparation and dissemination of regulatory guidance summaries and detailed communications to customer. Conduct research and work with business owners to identify responsibilities delegated by client organizations and ensure any follow-up communications are delivered.
qualifications/experience required
* 4 year college degree or equivalent combination of education and experience.
* 8+ years of quality and regulatory experience with proven experience in validation processes; 3+ years in a leadership role in a multiple or large site (600+ employees and associated revenue/customer base), preferably with smt and assembly manufacturing experience.
* possess and maintain technical expertise and knowledge of iso type quality systems, specifically those supporting qsr, fda and medical requirements as applicable to contract manufacturing of electronic devices.
* ability to interpret, understand and communicate regulatory requirements as applicable to the site, serving as topic expert as required in support of the corporation.
* capable of training validation, regulatory and quality system requirements, concepts, auditing methods and quality procedures as required.
* ability to provide day-to-day work direction for production/process auditor team leaders.
* effective communication and presentation skills.
* ability to work with minimal supervision and guidance.
* effective interpersonal skills.
the opportunity
this is a rare chance to be part of a high-growth, innovation-driven environment. You’ll join a company that powers some of the most mission-critical applications in the world—from life-saving medical devices to next-gen aerospace systems.
you’ll work alongside a passionate team of professionals committed to excellence, integrity, and global impact. Your role will directly influence product safety, quality, and compliance across borders.
seniority level
* mid-senior level
employment type
* full-time
job function
* legal
* manufacturing
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