• Lead regulatory compliance, engineering, and/or inspection readiness business unit(s)
operations, marketing and sales, and financial functions as needed and defined by
consensus vote of BioTeknica Executive management team.
• Plan, lead, and manage regulatory compliance, engineering, and/or inspection readiness
consulting projects as needed.
• Lead development of project plans, budget, and timelines using MicroSoft Project or
equivalent tool(s).
• Conduct initial communications with client regarding project needs, develop project content
and prepare SOW.
• Participate in marketing / sales as member of Business Development team.
• Establishes the strategic direction of the Business Unit development and operations;
executes this strategy in collaboration with Executive Management leadership.
• Staff projects working with, COO, Human Resources and recruiting functions.
• Provides constructive and timely performance evaluations.
• Supervise BioTeknica staff and client personnel as required.
• Write reports as required for tasks identified above.
• Follow BioTeknica’s policies, procedures, project templates, and reporting as required.
• Other duties as assigned.

Bachelor’s degree required, Master’s or MBA preferred

• Minimum of 15 years of diverse experience in Research & Development,
  Quality, Operations, Engineering, or Regulatory Affairs.
• Project management training
• Proficiency in project management software such as MicroSoft Project or equivalent
• Expert knowledge of cGMP and latest industry regulatory trends;
• Strong writing, oral, and presentation communication skills;
• Ability to influence and to interface effectively with both client executives and senior leaders
  as well as lower-level employees and BioTeknica staff / contractors;
•  Experience in managing an integrated multidisciplinary project team (PMP certification a plus);
•  Expert knowledge of cGMP and latest industry regulatory trends as well as applicable
  regulatory requirements such as 21 CFR 803, 806, 820, ISO 13485, ISO 14971, EU MDR;
• Self-motivated, efficient, and process oriented;
• Self-starter with ability to work independently. Needs little supervision or organizational
  structure support. Can handle dynamic changes and stressful client environments;
• Willing to listen to guidance or suggestions from BioTeknica Executive management team,
  project managers, and team members as appropriate;
• Good organizational skills, records management, and good documentation practices;
• Strong results orientation (driving to deadlines, financial targets, project goals, etc.);
• Proven knowledge and discipline relating to planning and execution.
• Consulting experience (not just FDA or industry experience)
• Experience in managing large initiatives, programs, or projects
• Expert in Medical Device and/or Pharma regulations
• Willing to travel 40-50% on average
• Someone Julie can foresee partnering with her to manage the business going forward (in addition to Mohit) as Sr. Partners begin to exit over time
• Can work well with others (Clients, peers, subordinates)
• Can provide constructive criticism in a positive manner
• Humble but assertive
• Responsive to customer needs (not necessarily wants)
• Ability to influence without authority
• Good communication skills (oral, written, body language, timely)
• Easy to do business with
• Professional (respectful, responsive, does what it takes to get the job done on time and with high quality)
• Monitors performance / progress and makes needed adjustments in a timely manner
• Willing to put team members above self
• Leads by example
• Leadership style – Inspires others to do their best

PREFERRED/DESIRED QUALIFICATIONS

• Project Management Professional (PMP) Certification.
• Expert knowledge of applicable regulatory requirements such as CFR 803 & 820, ISO 13485,
ISO 14971, and other applicable industry guidance for Medical Device suppliers,
manufacturers, and developers.
• Knowledge of applicable regulatory requirements such as CFR 211, 212, and other
applicable industry guidance for Pharmaceutical suppliers, manufacturers, and developers
• Knowledge of modern product development and project engineering principles, methods, and
practices.
• Proficient in auditing and Quality Engineering tools such as Six Sigma DMAIC.
• Professional presentation and strong interpersonal communications skills.

OTHER SKILLS

• Advanced knowledge of Microsoft Office (Outlook, Word, Excel, PowerPoint, Project, and
Visio)
• Critical Thinking — Using logic and reasoning to identify the strengths and weaknesses of
alternative solutions, conclusions, or approaches to problems.
• Reading Comprehension — Understanding written sentences and paragraphs in work related
documents.
• Active Listening — Giving full attention to what other people are saying, taking time to
understand the points being made, asking questions as appropriate, and not interrupting at
inappropriate times.
• Monitoring — Monitoring/Assessing performance of yourself, other individuals, or
organizations to make improvements or take corrective action.
• Coordination — Adjusting actions in relation to others’ actions.