Regulatory Compliance Consultant
Piper Companies is seeking a Regulatory & Quality Compliance Consultant in Boston, MA to join a firm supporting Quality Systems harmonization projects in the Medical Device and Life Sciences industry.
Assignment will start as a 2 year contract with potential for conversion or further extension.
Support the design, development, implementation and administration of company’s and clients’ quality assurance and regulatory compliance systems, programs and activities. Essential Job Functions:
· Support the maintenance of the quality system in compliance with US FDA quality system regulation, ISO 13485, MDD/MDR, international standards, and other regulations and standards as appropriate.
· Write, develop, and implement policies and procedures to ensure company compliance with domestic and international clinical, quality, and regulatory requirements.
· Support company interactions with external organizations including the FDA and international regulatory bodies. Serve as an alternate contact during audits and approve responses to audit reports, as necessary.
· Support the maintenance of company operational procedures, policies, and standards and documents representing the quality function within the company.
· Representative on project teams, providing quality assurance in accordance with customer requirements.
· Serve as an internal resource to address and resolve any questions or issues of a quality or regulatory nature.
· Direct and implement training programs consistent with organizational needs in accord with current US and international regulatory & quality requirements.
· Represent the company at industry meetings.
· Develop industry recognition as an expert in the quality and regulatory fields and identify and develop new business opportunities.
Qualifications & Education:
· Bachelor’s degree in a scientific discipline from a four-year college or university or equivalent job experience
· Minimum ten years’ experience in quality assurance/regulatory affairs in the medical device industry.
· Excellent grasp of all pertinent regulations for medical device design, development, and commercialization.
· Ability to define problems, collect data, establish facts, and draw valid conclusions.
· Experience communicating directly with health authorities in association with new product submissions and external auditing.
· Experience in professional service new business development and sales. Ability to develop and deliver presentations.
· Requires written and verbal communication and interpersonal skills. Ability to communicate and interact with individuals at all levels of responsibility internal or external to the organization.
· Experience simultaneously managing multiple projects.
· Ten years of experience in medical device field.