MANAGER, Regulatory Affairs / Quality Assurance
Starch Medical Inc. is currently recruiting for a Manager, Regulatory Affairs/Quality Assurance located in San Jose, CA.
Starch Medical Inc. was founded in 2007 and is a privately held medical device company based in San Jose, CA engaged in the design, manufacture and sale of absorbable hemostatic products.
Work with management and project team members to identify and execute regulatory and quality strategies to obtain and maintain commercial approval of Starch Medical products worldwide. Oversee the execution of complex project tasks relevant to quality initiatives and regulatory affairs from product inception to product launch.
Coordinates, writes, and completes submissions of regulatory documentation to Notified Body and other regulatory agencies around the world as appropriate. Ensures rapid and timely approvals/clearances of new products and provides regulatory support and direction for currently marketed products. Prepares responses to Regulatory authorities questions and other regulatory correspondence. Provides regulatory and quality guidance and direction to project teams and compliance activities. Conducts product and all marketing collateral reviews. Evaluates all proposed product modifications for regulatory and quality impact.
- Lead the development, documentation, and implementation of regulatory strategies for current and new technologies and product modifications. Collaborate with R&D to determine and execute pre-clinical test plans in support of regulatory submissions.
- Develop, coordinate, prepare and maintain International medical device submissions such as EU technical files & design dossiers and product registrations in markets such as Canada, Japan and Australia. Respond to regulatory authorities and distributors’ requests for additional information.
- Coordinate with external publishing resources for on-time delivery of high-quality regulatory submissions to regulatory agencies.
- Review product and process documentation for assigned projects to ensure compliance with change control requirements and determining whether regulatory submissions are required.
- Review and approve product labelling and advertising.
- Lead compliance activities related to GMP and ISO regulations and ISO quality system standards.
- Management of internal quality and regulatory compliance audits and the evaluation and monitoring of corrective actions.
- Work independently to perform studies in order to identify product improvement opportunities and/or to execute design change activities.
- Systematically identify root cause of product quality issues both independently and within cross functional teams.
- Provide scientific support for ongoing business activities including complaint investigation, CAPAs and general product stewardship.
- Ensure high level quality of projects, including experimental design, data summary and interpretation, report and manuscript preparation and adherence to applicable regulations and procedures.
- Bachelor’s degree in health profession, science and/or engineering field.
- Must have analytical skills, be detailed oriented and have good interpersonal skills.
- Knowledge of global regulatory guidelines and requirements.
- Minimum five years’ experience in regulatory affairs with at least three years’ experience in the medical device industry.
- Bilingual in Chinese and English is mandatory.
- Experience in working with EU is mandatory.
- Familiarity with requirements for clinical studies.
- Experience in use of electronic document management systems preferred.
- Ability to independently troubleshoot product quality issues of a complex nature
- Demonstrated track record of working within cross functional teams to successfully resolve customer complaints, to execute CAPAs, and/or to improve product designs.
- Excellent communication skills, both oral and written, with the ability to make technical information easy to understand for a non-technical audience.
- Minimum of 3 years Quality Systems or Quality Assurance experience with at least 2 years of experience in an FDA regulated industry (medical device, pharmaceutical, etc.)
- ASQ certification (e.g., CQA or CQE) is an asset.
- Knowledge of 21 CFR Part 820, Design Controls, ISO 13485 and familiarity with ISO 14971 are an asset.
Up to 20% travel (domestic and international) is required. This position will require the ability to adhere to all Starch Medical Inc. and industry safety requirements. This position will be based in San Jose, CA.