Associate Vice President Salary in San Jose, CA

An exciting opportunity to join an early Medical Device start up company based in California. focusing in the sector of Urology the ideal candidate for the role must have experience in this field and with BPH.Reports to the President/CEO and serves as a key and active member of the Senior Management/Executive team, interacting with the team to ensure business objectives are aligned and that the company is performingto operational objectives. Responsible for the overall medical device clinical regulatory program developmentand implementation, as well as the Clinical management of the company. Develops and executes regulatorystrategies that will expedite product development while minimizing costs. Ensures company policies,procedures and operating guidelines conform to laws, regulations and industry practices. Coaches and mentorsthe members of the organization ensuring appropriate levels of accountability for decision making regardingclinical, and regulatory requirements and clearly communicates cross functionally within the organization.MAJOR DUTIES AND RESPONSIBILITIES:• Provides management and leadership to the Clinical and Regulatory organizations in thedevelopment and implementation of clinical and regulatory strategies and processes to gain fastestto market product approvals.• Provides leadership and direction for significant deviation events that may impact compliance statusor significant business risk.• Provides counsel, training and interpretation of FDA, Health Canada, EMA, and other internationalregulatory requirements to all company personnel.• Directs and manages all regulatory submissions and communications to regulatory authorities.Ensures timely preparation of organized and scientifically valid submission. Evaluates need forexternal expertise for submission preparation and filing of all regulatory documents.• Maintains external positive relationships with key opinion leaders, medical directors and regulatoryofficials.• Identifies issues that may increase regulatory and corporate risks and proposes informed strategiesto address such risks.• Directs the development of systems, practices and processes to ensure effective ongoing review ofproduct design and/or manufacturing changes and adverse events. Maintains knowledge andfamiliarity with the regulatory environment and latest regulatory issues, and provides expertise intranslating regulatory requirements into practical, workable plans.• Develops and successfully executes clinical and regulatory strategies and implementation plans toensure product approval and adoption while meeting corporate objectives within applicableregulations and guidelines.• Directs team development and growth to meet company's clinical and regulatory requirementswhile remaining within budget.• Present to board of directors, when needed, all updates and short- and long-range planning forclinical and regulatory functions.Job Title: Vice President, Clinical Affairs• Provide support to CEO during company fundraising by providing documents and data to bepresented to potential strategic/investors.• Participate in meetings with potential strategic/investors as needed and present clinical andregulatory status.EDUCATION/EXPERIENCE REQUIREMENTS:• BS degree in scientific discipline, MS preferredSUPERVISORY RESPONSIBILITIES:• The EVP of Clinical, and Regulatory oversees all Clinical, and Regulatory roles within theorganization, including consultants.EXPERIENCE / KNOWLEDGE / SKILL REQUIREMENTSExperience• Minimum 10 years of leadership experience in clinical and/or regulatory and quality in medicaldevice and/or pharmaceutical industries.Knowledge/Skills• Working knowledge of ICH/GCP guidelines.• Knowledge of FDA, Health Canada, and EMA regulations and guidance• Clinical Trial Design and Management and Regulatory affairs certification or equivalent• 21 CFR 820 and ISO 13485 certification or equivalent

Director of Field Operations - Commercial Concrete - ConstructionSan Jose, San Francisco, Oakland and the Greater Bay AreaCompany Overview: We are a leading commercial construction company serving a diverse clientele in the greater San Francisco Bay area, including tech companies, private developers, healthcare providers, large education institutions, airports, mixed-use projects and so much more! Our projects range from sidewalks & parking lots to tilt wall industrial and big boxes to mid-rise and high-rise concrete structures. We pride ourselves on our commitment to quality, safety, and client satisfaction. We have a very strong backlog of projects into 2027. We are looking for a talented Senior Superintendent who has strong Construction Management and Field Operations leadership experience for this VP of Operations opportunity.Job Overview & Responsibilities:We are seeking a VP of Operations to lead multiple commercial projects and project teams simultaneously. This position will also have executive level leadership responsibilities and be a key member of our leadership team. This position will have influence and a seat at the table to the future of the company. This position will provide an opportunity to grow beyond running work and the field.Why Join Us:We foster relationships and help each employee achieve their career aspirations whether that is via advancement or via quality of life and leading a life that suits both their professional aspirations as well as meets their personal, family life goals and needs. We offer a culture that embraces both as well as a melting pot of talented people who all are best of class, top pedigree, intelligent and motivated with a passion for serving clients and bringing unique projects to life.Qualifications:Minimum of 15 years of experience as a Superintendent on a variety of commercial projectsExperience with project types including infrastructure, structure, parking, etc.Strong leadership and management skills, including the ability to manage a team and allocate resources effectivelyStrong analytical skills and attention to detailStrong communication skills, including the ability to communicate complex technical concepts to non-technical stakeholdersExperience with construction software toolsAbility to work independently and as part of a team in a fast-paced, deadline-driven environmentWe offer a competitive salary and benefits package, including health insurance, company truck, gas card, 401(k) plan, and 4 weeks of PTO plus paid holidays. If you are a driven, results-oriented leader with a passion for building projects and leading teams and a desire to work on challenging and rewarding projects, we encourage you to apply for this exciting opportunity. All inquiries are confidential.