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Senior Vice President, Regulatory and Quality

vor 2 Wochen

München, Deutschland Veranex, Inc. Vollzeit

Veranex is the leading service provider for medtech companies. Our global team of experts help clients anticipate challenges and find solutions throughout the development and commercial lifecycle. Together, we accelerate new technologies to market and improve patient outcomes.
**About This Role**:
We are seeking an experienced Vice President or Senior Vice President of Regulatory & Quality to provide leadership and strategic business support to regulatory affairs and quality engineering staff. The Vice President / Senior Vice President of Regulatory & Quality oversees regulatory affairs and quality engineering initiatives designed to address critical business challenges and achieve organizational goals and objectives.
Vice President, Regulatory & Quality - EU
**What You Will Do**:
Works with executive leadership to develop and execute department operations initiatives to meet service line and department goals and standards:

- Acts as an operational and analytical thought partner to the EVP and leadership team to define, achieve, and measure key service line operational and financial goals
- Advocates for strategic initiatives and develops approaches (models, frameworks, presentations, recommendations, etc.) for leadership team evaluation and decision-making
- Reports progress, operational issues, and organizational opportunities to the EVP
- Oversees, manages, and participates in the department's day-to-day project delivery to ensure quality of output
- Provides input into business development strategy, scoping, and processes
- Leads the refining of operational processes, systems, and infrastructure, increasing performance and enhancing employee and client experiences
- Reviews, analyzes, and addresses gaps in service excellence, policies, and/or procedures proactively; identifies issues and bring forward solutions
- Evaluates performance by analyzing and interpreting data and operation metrics to meet quality/performance metrics
- Manages department growth, employee development, client satisfaction, and general project outcomes within the assigned department
- Proactively engages with cross-functional stakeholders to identify interdependencies, resolve issues, and champion strategic initiatives
- Manages department change initiatives by continuously assessing the department's needs, championing change initiatives, and overcoming obstacles impeding organizational success
- Prepares the department for both organic growth and potential mergers/acquisitions
- Communicates and explains new operational objectives, policies, or procedures while projecting a positive image of Veranex to employees, customers, industry, etc.
- Leads, motivates, and supports the department withing a time-sensitive and demanding environment, including oversight of recruitment, conflict resolution, and client challenges
- Provides leadership to the department, while fostering a culture of accountability, professional development, high-performance, and ethical behavior

**Qualifications**:
**Required skills**:

- Bachelor’s or Master’s degree in a technical-related field plus a minimum of 15+ years of combined regulatory and quality experience (primarily with medical devices, IVDs, and/or software as a medical device SaMD), or an equivalent combination of education, training, and experience.
- Experience with both start-up and mid-size/large medical device companies
- Experience with RQS consulting (ideally has worked within a consultancy and/or has directly worked with consultants in the past)
- Has managed large RQS teams (40+ people), ideally global teams in the EU
- Experience with integrating teams and change management
- Operationally focused, with strong people orientation/soft skills
- Strong industry relationships
- Good professional presence, poised, and positive/growth mindset
- Strong leadership, collaborative, and interpersonal skills
- Excellent communications (written, verbal, listening) skills and oral presentation ability, as well as the ability to forge successful relationships with internal and external partners
- Strong attention to details and a downstream understanding of their impact
- Ability to look for and advocate for more efficient and effective methods/processes of operations focusing on key performance metrics around reliability, efficiency, cost
- Capacity to lead a team through changes and innovation
- Ability to provide innovative approaches that yield practical and scalable solutions

Senior Vice President, Regulatory & Quality - US/EU
**What You Will Do**:
Works with executive leadership to develop and execute department operations initiatives to meet service line and department goals and standards:

- Acts as an operational and analytical thought partner to the EVP and leadership team to define, achieve, and measure key service line operational and financial goals
- Advocates for strategic initiatives and develops approaches (models, frameworks, presentations, recommendations, etc.) for leadershi