Regulatory Affairs Manager
At Adaptiiv Medical Technologies Inc., we help transform the patient experience with 3D printed patient-specific accessories for use in radiation therapy. We foster a culture of innovation, collaboration, diversity, creativity, growth and success. We are always looking for individuals who have exceptional talent and an entrepreneurial drive to contribute to the ongoing fight against cancer.
If you are passionate about making a difference, we would like to hear from you!
Reporting to the Director, Finance & Operations, the Regulatory Affairs Manager will act as the Quality Management Representative with authority to ensure the quality management systems’ requirements are effective and maintained in accordance with ISO standard, FDA, CE, EU, & Australian regulations. This position plays a significant role in overseeing and improving quality standards, directives, and policies for Adaptiiv. The role requires experience working in a fast-growing organization, with a proven track record of successful leadership capabilities, directing day to day activities with regulatory liaisons, and providing ongoing coaching to develop the skills of the other employees.
Job Duties & Responsibilities
- Support the Adaptiiv team by helping to enhance and/or harmonize the Quality System.
- Partners and collaborates with the Director to ensure customer requirements are met and quality measures and compliance strictly adhered to.
- Provide a strong voice and direction for the Operations and Quality group.
- Lead (or direct) the internal audits and collaborate internally to execute routine, risk based monitoring and auditing of relevant internal activities to applicable regulations, guidelines, policies and procedures; identify potential areas of compliance vulnerability and risk; oversee the implementation of corrective action plans as necessary; and generate reports on monitoring, auditing and risk assessment for the business; Lead external audits including customer, and supplier audits to ensue execution of the annual audit plan.
- Ensure all audit observations are communicated, analyzed, and remediated in compliance with internal policies and applicable regulatory requirements.
- Direct all aspects of the internal non-conformance management systems, specifically CAPA, deviations, risk assessments, Supplier Corrective Actions Reports (SCARS) and Plans or Supplier Questionnaires.
- Evaluate and challenge the quality system and practices within the site to continuously improve the efficiency of those systems and their levels of compliance.
- Recommend and implement corrective actions to support continuous improvement programs.
- Support and oversee all QA Documentation ensuring related procedures reflect current practice clearly and accurately.
- Support new product development, which includes oversight (but not ownership) of the design control process in partnership with development teams.
- Review controlled documents such as quality manual, quality policies, standards and regulations per the periodic document review requirement.
- Lead and manage regulatory filings for commercial product release (FDA 510k, CE Mark).
- Master’s or bachelor’s degree in health science or an engineering related field.
- Minimum 5-7 years progressive management experience in Quality Assurance, preferably in a diagnostics or medical device environment.
- 5-7 years experience with instrumentation, medical devices that have both a hardware and software/firmware component; also including the development of new instrumentation.
- Skilled in developing collaborative internal and external relationships with experience in building teams, through coaching and development.
- Demonstrated ability to work as a team player with multi-disciplinary project teams and ability to independently solve problems, work cross-functionally, and effectively negotiate.
- Must be able to effectively interact with and present to senior management at all levels, as well as to external audiences/customers and auditors/inspectors.
- CDMR, 21 CFR Part 820, MDSAP, ISO 9001, ISO 13485 and EU regulations, as well as familiar with Australian regulations.
- Experience managing regulatory audits from customers, regulatory or compliance agencies.
- Ability to analyze complicated situations and development actions plans for the mitigation and/ or reoccurrence of these situations.
- Lead or Internal auditor training (preferred).
- Lean or Six Sigma green or black belt training (certified preferred).
- This position is full-time (37.5 hours/week) with annual salary commensurate with experience and qualifications. Comprehensive health benefits package included.
|Reports to||Director, Finance & Operations|