Vice President of Quality and Regulatory
Full Time. Louisville, CO
The Vice President of Quality and Regulatory is responsible for all quality and regulatory activities at Bolder Surgical, including but not limited to product quality, the company’s quality management system, regulatory compliance, and submissions. Candidate must be versatile and flexible to work successfully within an entrepreneurial company.
- A key and active member of the leadership team, working collaboratively to ensure regulatory and quality objectives are met and aligned with Bolder Surgical’s corporate objectives.
- Lead and mentor the Quality Assurance and Regulatory Affairs organization, delegating appropriate levels of accountability for decision making and clearly communicating requirements and plans cross-functionally within the organization.
- The Quality Management Representative and primary point of contact with the Company’s Notified Bodies and external auditors. Ensure the company is in full compliance with regulatory agencies.
Quality Assurance and Compliance
- Responsible for the strategic leadership of the Quality Management System (QMS).
- Set, maintain, and train cross-functional teams on regulatory policies and quality standards for all quality systems and ensure compliance with applicable regulations worldwide.
- Facilitate management review of Bolder Surgical’s QMS to monitor performance and create/support process enhancement initiatives to drive continuous improvement.
- Drive execution of QMS processes through programs, policies, and functions that support corporate and product quality.
- Collaborate cross-functionally with internal departments on strategy development, risk assessments, and implementation of quality principles and regulatory requirements.
- Develop and execute a quality design and quality assurance strategy for new product development, changes, and improvements.
- Effectively create and support process enhancement initiatives to maintain an environment of continuous improvement throughout the organization.
- Ensure effective coordination of investigations, root cause analysis, risk assessments and implementation of change control, and corrective and preventive actions to the adhered timelines as appropriate.
- In support of the quality system, provide effective leadership support, training, and guidance to all company personnel.
- Provide management and leadership to the Regulatory Affairs organization in the development and implementation of regulatory strategies and processes to inform commercialization plans approvals worldwide.
- Lead corporate regulatory strategies related to new product development and prepares documentation for worldwide regulatory submissions for obtaining Premarket 510(k) clearances, Premarket Application approvals, CE-marking, and international distributor registrations.
- Provide regulatory guidance to cross-functional groups regarding all aspects of manufacturing, quality, preclinical and clinical development, and testing for products.
- Oversee preparation and filing of all regulatory documents with the FDA and international regulatory agencies within applicable regulations and guidelines.
- Provide regulatory oversight and guidance for compliant product advertising and promotion.
- Integrate global regulatory understanding and responsibilities in developing strategy and development of regulatory submission documents.
- Excellent communicator
- Good written skills
- Strong knowledge of quality systems in a manufacturing environment
Job Requirements and Qualifications
- Minimum of BS degree in a scientific discipline, preferably life sciences, biomedical, or other engineering science. MS or Ph.D. a plus
- Minimum 10 years progressive quality and regulatory experience in the life science/biotechnology manufacturing environment, preferably with regulated medical devices.
- Regulatory certification (RAC) and auditor (CQA) qualifications a plus.
- $140K – $215K
- Equity Participation
- Medical, Dental, Vision
- Life and Disability insurances
- Paid Time Off and Paid Holidays
- Health Savings Accounts (HSA) and Flexible Spending Accounts (FSA)
- 401K retirement savings plan
- Parental Leave
- Voluntary Life Insurance for employees, spouses, and children
- Voluntary Critical Care and Accident
- Insurances for employees, spouses, and children
- Tuition Reimbursement
- Referral reward bonuses
- Corporate discounts
- Employee Assistance Program
Work Environment/Other Information
- Ability to work flexible hours.
- The employee is regularly required to sit, stand, walk, and reach with hands and arms, use hands to finger, handle, feel, and be able to talk and hear. Specific vision abilities required by this job include close vision, color vision, and the ability to adjust focus.
- Ability to lift or move up to 25 pounds
Bolder Surgical is a medical device manufacturer based in Louisville, CO that has redefined surgery particularly in small spaces. Founded in 2010, we have developed and are marketing laparoscopic surgical instruments including the world’s smallest low-power 3mm Vessel Sealer & Generator and the world’s first ever 5mm linear Stapler. As the company continues to bring unique, high quality products to market, activities around R&D, quality, regulatory, sales, marketing, and manufacturing are increasing dramatically. The company is well capitalized and is poised for substantial growth through the coming years.