Quality & Regulatory Affairs Manager

SUMMARY:  This position is responsible for providing regulatory direction, strategy, and support for our medical device clients in accordance with applicable regulatory requirements. They will be responsible for developing regulatory strategies and plans. They will also be responsible for planning, organizing, and preparing regulatory documents for submission. In addition, this position is responsible for supporting the creation, maintenance and review of quality assurance systems that promote Innovenn and its clients’ quality in delivery of services and/or products.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Develops and implements regulatory strategy and plans for projects as assigned to ensure client and agency needs are met. Actively drives interactions with regulatory bodies as assigned ensuring information meets agency requirements for form and content in collaboration with client.

Provides regulatory support for the development of technical files conforming to regulatory body requirements.

Assesses regulatory files to determine conformance to applicable regulatory requirements.  Provides guidance to project teams on addressing any compliance issues or risks. 

Assists in the preparation, coordination, and management of simple and complex regulatory submissions for medical device in accordance with applicable regulations.

Translates regulatory agency requirements into practical, workable requirements; assists in the coordination of internal/external authoring/review/comment adjudication and finalization of submission related documents. 

Provides regulatory expertise in comments during document review, mindful of regulatory requirements pertaining to document content.

Interfaces with internal and external functional groups in the preparation, review, compilation, finalization submission and posting of regulatory submissions supporting Innovenn in meeting its quality and regulatory obligations to clients. Acts as liaison between regulatory and other functional areas; represents regulatory in cross-functional team meetings providing expertise on regulatory guidelines and requirements.

Assists with developing corporate quality objectives and plans to ensure the quality management system (QMS) is implemented and managed to meet the quality objectives and applicable standards and regulations. This includes managing changes to the QMS ensuring its integrity.

Develops, implements, improves and maintains the QMS by ensuring its effectiveness and compliance with regulatory requirements, corporate quality policies, and applicable industry quality standards for Innovenn and its clients.

Identify key performance indicators/metrics and preventive measures; monitors key processes and develops and implements corrective actions and verification activities to ensure QMS effectiveness.

Provides reports to leadership regarding the effectiveness of the quality management system and provides identified areas of the QMS for improvement. 

Provides awareness of regulatory requirements and trains teams on quality and regulatory principles, requirements, regulations, standards, and good practices facilitating company-wide adherence

Drives continuous improvement by supporting internal and external audits, and championing root cause analysis and CAPA to make change and reinforce the company’s quality culture.

Provides regulatory and quality support when selecting and qualifying suppliers and vendors by ensuring compliance with internal procedures and regulatory requirements.

Organizes and maintains the document control processes ensuring document accuracy, integrity, security, and quality. This includes managing changes to documents and records reviewing them for adequacy prior to issuance. 

OTHER DUTIES AND RESPONSIBILITIES:

Maintains and increases job knowledge by studying the state-of-the-art, ongoing research in the field, etc.; participate in educational opportunities; read professional publications; maintain personal networks; participate in professional organizations.

Adheres to stated policies and procedures relating to health and safety, and quality management ensuring highest quality project deliverables to clients.

Note that this position description is not designed to cover or contain a comprehensive listing of all activities, duties or responsibilities that are required in the performance of this job.  Duties, responsibilities, and activities may change at any time with or without notice

MINIMUM EDUCATION, SKILLS AND EXPERIENCE REQUIRED:

BA or BS degree in health or science related discipline. Five years of professional quality and regulatory experience in medical device or drug.  Experience in managing quality systems and regulatory submissions (pre-submissions, 510(k), De Novo, PMA). 

Extensive experience in FDA and EU medical device regulations also required.

Demonstrated experience as a self-starter and a fast learner; must work efficiently responding to changing priorities, able to work independently and within a team; must have excellent problem-solving skills, analytical and research skills and attention to details.  Must consistently meet deadlines, manage projects across several collaborators and handle multiple projects simultaneously. Excellent written and verbal communication skills are required and must be able to write clear reports, proposals, etc., and efficiently discuss the same with other scientists, engineers, and clients.

COMPANY BENEFITS AND PERKS:

• Great Corporate Culture and Team 
• Competitive Compensation 
• Ten (10) Paid Holidays
• 3 Weeks/Year PTO Accrual Rate at Start
• Medical (both HMO and PPO Options), Dental and Vision - Employer paid 70% 
• Employer paid Long-term Disability, Short-term Disability, AD&D/Life Insurance - $10,000
• 401k
• Employee Assistance Program (EAP)