Accure Acne, Inc. QUALITY ASSURANCE / REGULATORY AFFAIRS MANAGER Boulder, CO · Full time

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This position reports directly to the CEO.  Specific duties and responsibilities include, but are not limited to:

·       Develop, implement, and maintain all aspects of an effective quality management system that meets the requirements of the FDA QSRs, ISO 13485, MDSAP, the EU MDD/MDR, and all other applicable standards as identified for commercialization of the medical devices.

·       Direct internal audits to monitor the effectiveness of the quality management system.

·       Serve as Management Representative to oversee and report on the effectiveness of the QMS to executive management, report on improvements needed, and ensure awareness of quality, regulatory and customer requirements throughout the company.

·       Working as part of a cross-functional team, ensure that products are designed, developed, and manufactured in accordance with internal procedures and meet the requirements set forth in the applicable regulations and standards.

·       Develop and monitor supplier performance program according to company policies, including on-boarding new suppliers and managing current suppliers (auditing according to supplier quality agreements where necessary).

·       Implement company feedback and monitoring and measuring programs (e.g. CAPA, NCR, Complaints, Internal Audits) according to company policy and regulatory requirements.

·       Act as internal liaison with regulatory agencies and certifying bodies for site inspections and all matters regarding compliance with quality system requirements and product complaints/problems.

·       Review documentation for, and coordinate release of, devices manufactured by and for the Company

·       Administer corporate documentation vault and manage company document, records, and change control.

·       Continuously improve QA processes and procedures to meet business and compliance needs.

·       Develop and implement (with Engineering & Marketing) the corporate regulatory strategies for new products and marketed products based on US, EU and other international standards, regulations, legislations, and guidance.

·       Coordinate (with Engineering & Marketing) and prepare all US and International regulatory submissions.

·       Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.

·       Compile and maintain regulatory documentation databases or systems as required (e.g. UDI, Establishment Registrations & Listings, etc.).

·       Manage product complaint handling and closure. Work with technical team as required, to capture analyses and appropriate remediations. 

·       Develop and/or conduct employee training.

·       Review and approve all product labeling and advertising/ promotional materials ensuring compliance with relevant markets.

·       Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.

·       Identify new or updated relevant regulations, guidance documents, international standards, or consensus standards and provide interpretive assistance.

·       Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.

·       Coordinate, report, and communicate recall or market withdrawal activities as necessary.

Qualifications

·       Bachelor’s degree, preferably in a scientific discipline or engineering.

·       Minimum 7 years Regulatory Affairs and Quality Assurance experience, with at least 4 years’ experience with medical devices.

Specific Skills Required

·       Demonstrated experience in Quality System Regulation compliance, clearance of Class I and II via FDA 510(k) process, and CE Marking of Class I through Class IIa & IIb (EU) medical devices,

·       Advanced working knowledge of US and EU medical device regulations / legislation and applicable international standards including CAN MDR, ISO 13485, and MDSAP to establish strategy, policies and procedures,

·       Experience interacting directly with US and International health authorities (including audits).

·       Knowledge of 21 CFR Part 11 compliance and medical device software design verification/validation.

·       Ability to work effectively with a cross-functional team to balance conflicting demands between Regulatory, Quality, R&D and Operations, and ensure compliant solutions,  

·       Ability to work effectively in a team environment and build strong working relationships, 

·       Ability to prioritize, multi-task and adapt to change, 

·       Excellent organizational skills and attention to detail, 

·       Strong communication skills, both oral and written.

Additional Information

·       Position is on-site in Boulder, Colorado with options for remote work if approved by a manager and only as an exception.

·       US and International travel may be required, up to 20%.