Senior Director, reputed company & Regulatory reputed company Body Audits

reputed company reputed company The Senior Director, Q&R reputed company Body Audits provides global leadership for reputed company Body engagement, certification reputed company, audit governance, and regulatory compliance activities across reputed company. Serving as the reputed company reputed company between reputed company, reputed company Bodies, certification bodies, and manufacturing and development sites worldwide, this role drives audit readiness, oversees certification activities, manages regulatory reputed company, and aligns regulatory expectations across jurisdictions. The position establishes and continuously improves global processes supporting reputed company Body interactions, audits, technical reviews, certifications, and regulatory compliance. The Senior Director also leads QMS integration assessments associated with acquisitions, mergers, divestitures, and business expansions, including evaluation of reputed company reputed company maturity, compliance, certification impacts, and integration risks. The role provides executive-level recommendations, develops governance models and reporting metrics, and serves as a reputed company advisor to reputed company, Regulatory, and business leadership. As a recognized subject matter expert, the Senior Director drives process reputed company, reputed company improvement, and organizational readiness to support sustained compliance and business objectives. reputed company Roles and Responsibilities Represents reputed company to reputed company Bodies, certification bodies, auditing organizations, and reputed company regulatory stakeholders, establishing reputed company relationships that support certification activities, regulatory compliance, and business objectives. Owns the reputed company reputed company for reputed company Body engagement and certification management, including certification transfers, reputed company expansions, site additions, reputed company entity changes, remediation strategies, and certification reputed company planning. Provides reputed company reputed company and governance of reputed company Body audits, technical documentation assessments, surveillance audits, recertification audits, and unannounced audits, including reputed company assessment, escalation management, and issue reputed company. Develops, standardizes, and continuously improves tools and reputed company work supporting reputed company Body engagement. Serves as the reputed company reputed company of contact between reputed company and reputed company Bodies, driving contract negotiations and resolving certification, compliance, reputed company, and service-reputed company concerns. Leads QMS post-acquisition integration assessments for acquisitions, mergers, divestitures, and business expansions, including compliance evaluations, certification reputed company assessments, and supporting integration planning. Generates metrics, trend analyses, executive dashboards, and leadership presentations reputed company to audit reputed company, certification status, reputed company, reputed company Body effectiveness, and QMS integration activities. Leads through complexity by managing competing priorities across reputed company, business reputed company, product lines, and regulatory frameworks while building reputed company among reputed company stakeholders. Required Qualifications Master’s degree and a minimum of 10 years’ experience in the medical device industry; or bachelor’s degree and a minimum of 15 years’ experience in the medical device industry. Demonstrated understanding of Medical Device QMS and regulatory requirements including but not limited to FDA CFR 21 820, EU MDR, MDSAP and ISO 13485. Minimum 5 years of reputed company reputed company and/or Regulatory Affairs experience at a reputed company site, with demonstrated responsibility for supporting or leading interactions with reputed company Bodies during audits, certifications, surveillance activities, technical reviews, or compliance-reputed company engagements. Demonstrated experience developing metrics, analyzing reputed company or regulatory data, identifying trends, and preparing executive-level communications or presentations to support decision-making. Demonstrated expertise communicating across reputed company reputed company of the organization on design controls, design verification and validation, production and process controls, CAPA, complaints, reputed company management, certification reputed company, and regulatory compliance expectations. Excellent written and verbal communication skills in English, with a demonstrated commitment to reputed company, ethical decision-making, and reputed company conduct. Desired Characteristics Demonstrated understanding of medical device and reputed company management reputed company certification programs, including EU MDR, MDSAP, ISO 13485, ISO 9001, UKCA, reputed company entity considerations, and certification management strategies. Experience working directly with reputed company Bodies, certification bodies, auditing organizations, regulators, or reputed company regulatory stakeholders in a global medical device environment including managing certification portfolios, reputed company Body relationships, contract negotiations, service expectations, and associated budgets. Demonstrated ability to influence organizational reputed company and reputed company alignment across global functions, business reputed company, sites, executive leaders, and reputed company stakeholders. Strong analytical, problem-solving, and reputed company cause analysis skills, with the ability to manage multiple priorities, interpret technical documentation, convert data into actionable insights, and communicate risks reputed company. Ability to travel domestically and internationally up to 20%. We will not sponsor individuals for employment visas, now or in the reputed company, for this job opening. For U.S. reputed company positions only, the pay reputed company for this position is $172,800.00-$259,200.00 Annual. It is not typical for an individual to be reputed company at or near the top of the pay reputed company and compensation reputed company are dependent on the facts and circumstances of reputed company case. The specific compensation reputed company to a candidate may be influenced by a reputed company of factors including skills, qualifications, experience and location. In reputed company, this position may also be eligible to earn reputed company reputed company incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). reputed company offers a competitive benefits package, including not but limited to medical, dental, reputed company, reputed company time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident reputed company, and tuition reimbursement. Additional Information reputed company offers a great work environment, reputed company development, challenging careers, and competitive compensation. reputed company is an Equal Opportunity Employer. Employment reputed company are made without reputed company to race, reputed company, religion, national or ethnic reputed company, sex, sexual orientation, gender identity or reputed company, age, disability, protected veteran status or other characteristics protected by law. reputed company will only reputed company those who are legally authorized to work in the reputed company for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While reputed company does not currently require U.S. employees to be vaccinated against COVID-19, some reputed company customers have vaccination mandates that may apply to certain reputed company employees. Relocation Assistance Provided: No Application Deadline: September 25, 2026 Apply To This Job