**12655BR** **Title:** VP, Global Regulatory Affairs **Job Description:** Assume worldwide responsibility, while working closely with the SVP, Global Quality & Regulatory Affairs, to map the optimal and contingent regulatory strategies to support product registrations, compliance with domestic and international regulations and marketing message. Obtain worldwide regulatory approvals. Assure compliance to domestic and international regulatory requirements for all regions and supervise a global organization encompassing global regulatory affairs. Job duties: + Lead development and implementation of efficient and economical regulatory strategies for worldwide product registrations, regulatory compliance, and marketing support. + Develop and facilitate collaborative relationships with domestic and international federal agencies. + Lead the preparation of regulatory submissions for product registration in the U.S. and international countries. + Negotiate directly with regulatory agencies and/or country distributors. + Lead the Regulatory Affairs department. + Inspire, motivate, and communicate vision; build consensus toward adoption of and commitment to new standards. + Assess the current state of the Regulatory Affairs department (organizational structure, competencies, and skills). + Provide guidance on legal and regulatory issues related to advertising, labeling, public disclosures, corporate communications, and other public relations activities. + Assure timely regulatory clearances for key product launches. + Develop and implement a strategic vision and tactical plans consistent with the organizational strategic objectives. + Coordinate regulatory agency and notified body inspections. + Promote awareness of applicable regulatory requirements. + Travel as needed. + Comply with applicable Laws and Regulations, adhere to Quality Management System process and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization. \#LI-DNI **Auto req ID:** 12655BR **Location:** Aliso Viejo, California, USA **Department Name:** 523-RAQA Regulatory **Qualifications:** 1. Minimum of a BA/BS degree within a technical related discipline or equivalent experience. 2. A minimum of fifteen (15) years of applicable experience in global Regulatory Affairs for U.S., EMEA, Japan and China in a medical device environment. 3. A minimum of ten (10) years of management experience leading professionals. 4. Significant experience in the US PMA/IDE/HDE environment including successful PMA clearances. 5. Prior medical device development and approval experience and thorough understanding of the medical device industry and all stages of product development. 6. A successful track record in coordinating and interacting with multiple and diverse business units. 7. Successfully taken multiple products through development and regulatory cycle both domestically and internationally. 8. A proven track record of regulatory agency compliance, utilizing people effectively and managing tightly against performance metrics that are highly visible. 9. Demonstrated successful track record of commercializing several FDA approved products from product ideation phase to volume production phase. 10. Ability to attract top talent and provide the necessary leadership and mentoring to address new product initiatives outside of the company's core product and process technology domain. 11. Experience leading a global Regulatory Affairs organization of similar size and scale. 12. Demonstrated success in working with the internal organization in matters concerning compliance to regulation. 13. Demonstrated strong business acumen with an understanding of the financial implications of the regulatory processes. 14. Experience with utilizing outside consultants and service providers in support of clinical validation studies and trials. 15. Excellent written and verbal communication skills. 16. Proficient computer skills including MS Word, Excel, Outlook, and Teams. **Desired Qualifications** 1. Master’s degree preferred. 2. Knowledge of QSR, MDD, CMDR, EN ISO 13485, GCP, RDC ANVISA 16/2013, MHLW MO169, TG(MD)R Sch 3, TG(MD)R Statutory Rules No. 236, EN ISO 14971, and any applicable requirements of regulatory authorities participating in the MDSAP program. 3. Ability to balance compliance requirements and business needs. 4. Demonstrated Program Management skills. **External-Facing Title:** VP, Global Regulatory Affairs **Posting Country:** US - United States We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, ethnicity, disability, religion, national origin, gender, gender identity, gender expression, marital status, sexual orientation, age, protected veteran status, or any other characteristic protected by law.