BIOLASE, Inc. is a medical device company that develops, manufactures, markets, and sells laser systems in dentistry and medicine and also markets, sells, and distributes dental imaging equipment, including CAD/CAM scanners. BIOLASE's products are focused on better enabling clinicians to repair and restore patient's dental conditions while reducing the pain, fear, and anxiety generally associated with dentistry. BIOLASE is committed to elevating the standard of care in dentistry, while enabling clinicians to achieve better business returns.
We are currently seeking a Senior Regulatory Affairs Specialist responsible for the development, submission and maintenance of various global regulatory submissions registrations, and compliance adherence and reporting. This position will work closely with the head of Director of Regulatory Affairs and Quality Assurance in the preparation of regulatory strategies for new products, product changes, as required, to ensure continued compliance and timely market release.
ESSENTIAL DUTIES AND RESPONSIBILITIES
This position of responsible for management of all aspects of international registrations in compliance with medical device regulations. Job duties:
- Coordinate, compile, and supply international submission packets for product registrations. Manage communication and maintain good working relationship with distributors/economic operators and/or regulatory authorities.
- Support each affiliate/distributor on a case-by-case basis to address custom requirements, and negotiations with Ministries of Health in each respective country.
- Create and maintain an international registration database.
- Lead in organization and preparation of FDA 510(k) submissions and Canadian License submissions.
- Represent Regulatory Affairs in various project meetings and provide on-going support to cross-functional teams, including Product Development, Quality, and Marketing to ensure regulatory requirements are met including compliance with design controls, risk management. Provide guidance on domestic and international filing, testing and standards requirements.
- Interpret and apply medical device and quality system regulations to ensure conformance in all areas of the organization. Assist in the development and implementation of procedures pertaining to the Biolase quality systems to ensure compliance.
- Prepare / assist in preparation of technical documentation following the requirements of the EU medical device regulations for class I and II devices including clinical reports.
- Coordinate FDA Small Business Designation application process with Finance and submit applications. Obtain Certificates to Foreign Government (CFG) and/or Free Sales Certificates (FSC).
- Assist in evaluation of proposed product modifications for global Regulatory impact. Conduct pre-submission identification of requirements and strategy.
- Review/approve various quality records such non-conforming reports, CAPAs, complaints, as well as documentation supporting design history files and risk management files to ensure appropriate Regulatory oversight and compliance.
- Assist in product field corrective actions and vigilance reporting activities, as well as internal and external audits and inspections.
- Lead, organize and facilitate internal audits including ISO/notified body, FDA, and country requested audits as requested.
Skills & Experience
EDUCATION / EXPERIENCE/ SKILLS
- Bachelor’s degree in biological/physical science or equivalent and a minimum of 5 to 7 years of regulatory affairs work experience;
- Experience in applying quality control and design control requirements;
- Experience in project management;
- Working knowledge of domestic and international medical device regulations, standards, guidance documents including ISO 13485, MDSAP, MDR, 21CFR820, etc.
- Hands-on experience with global regulatory submissions
- Experience with writing technical documentation to obtain or maintain CE mark
- Knowledge of UDI requirements, design controls and risk management and post market surveillance.
- Ability to work independently and as part of a team
- Keep-up with fast-pasted environment
- Ability to read, analyze, and interpret common scientific and technical journals, legal documents and various guidance documents, ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community in a timely manner.
- Ability to effectively present information to top management, excellent written and verbal communication skills to include interacting with both internal personnel and external organizations (regulatory authorities, customers, distributors, etc.).
- Ability to define problems, collects data, establish facts, and draw valid conclusions. Good analytical thinking, organization, problem solving, and investigative skills
BIOLASE is an Equal Opportunity Employer (EOE M / W / Vets / Disabled)