Head of Quality and Regulatory Compliance Services
Engineering, Quality and Regulatory Consulting
Coral Gables, FL
BioTeknica is an elite consulting firm for large strategic companies such as Abbott, Stryker, Medtronic, etc., focused on quality and compliance, FDA inspection readiness, quality engineering, and validation projects for Medical Devices, Biologics, and Pharmaceutical Industries. We are hiring a Head of Quality/Regulatory Compliance for BioTeknica.
We have partnered with Julie Larsen, COO & Principal, to hire our Head of Regulatory Compliance to lead MedTech regulatory compliance activities including Enforcement Actions such as a warning letter or consent decree. This position will operate as the tactical leader for U.S. and EU regulatory compliance while also supporting FDA or Notified Body submissions and management for large-scale initiatives and projects.
**Note – Must have MedTech Consulting experience and be willing to travel > 40%**
• 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
• 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
• 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
• Proficient in auditing and Quality Engineering tools such as Six Sigma DMAIC.
• Professional presentation and strong interpersonal communications skills.
• Advanced knowledge of Microsoft Office (Outlook, Word, Excel, PowerPoint, Project, and
• 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
• 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
• 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.
Walking the regulatory compliance tightrope is not easy, but with BioTeknica’s real-world quality expertise, life science manufacturing clients gain a competitive edge.
Medical device, diagnostics and pharmaceutical manufacturers are having to do more with less. They’re responsible for staying on top of an ever-evolving set of domestic and international regulations while bearing responsibility for every step in the global supply chain, increasing productivity and profitability and understanding how regulations apply to each specific product. BioTeknica provides engineering, quality and regulatory solutions that are S3 – Simple, Systematic and Sustainable for today’s evolving regulatory environment. Our team of skilled scientists, regulatory professionals and engineers have worked with hundreds of companies and has a solid track record of solving regulatory and compliance challenges for corporations, from Fortune 500 companies to start-ups. Contact us.
Balancing compliance and your bottom line is our top priority.
BioTeknica is an ISO 9001:2015 Certified Company.
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