Full Time. Louisville, CO
The RAQA Associate is responsible for supporting all regulatory activities at Bolder Surgical including but not limited to product registrations, technical documentation maintenance, device modification review, marketing material review, clinical evaluation support, and quality management system support. The ideal candidate is willing to take on a variety of tasks as needed to support the regulatory affairs and quality department.
- Supports 510(k) premarket notification activities.
- Supports international product registrations in both the pursuit of new registrations and the maintenance of current registrations.
- Prepares and maintains product Technical Documentation compliance to the EU MDR.
- Participate as the Regulatory Affairs representative in Design Modification review meetings.
- Perform Regulatory Impact Assessments.
- Assist in the organization and communication of Design Modifications to International Distributors.
- Perform Regulatory Compliance reviews of new and revised marketing material.
- Support activities related to Clinical Evaluations compliant with the EU MDR.
- Support the development of new and modified Regulatory Affairs procedures.
- Assists in the maintenance and organization of Regulatory records.
- Support compliance with and maintenance of the Bolder Surgical Quality Management System as required.
- Developing dashboards, metrics, and reports for communication to management. Other duties as assigned.
Job Requirements and Qualifications
- Four-year college degree with 1-2 years related experience in a medical device quality/regulatory capacity or a master’s degree in a Regulatory Affairs or related discipline with 0–1-year related experience in a medical device quality/regulatory capacity.
- Excellent communicator
- Excellent analytical and writing skills
- Highly organized, detail-oriented
- Familiarity with regulatory requirements in major international markets
- 67K – 91K – (Salary to be determined by the applicant’s education, experience, knowledge, skills, and abilities, as well as internal equity and alignment with market data.)
- 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 Enviornment/Other Information
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- 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.
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.