Medical Device Quality

3 weeks ago

Waltham, United States Client of Nachman BioMedical Full time

Great QA/RA Project Management opportunity with a well-established and growing developer of a range of specialized medical temperature sensing devices for clinical and consumer settings. The experienced and successful QA/RA Project Manager in this new role will report to the VP of QA/RA and work with a cross functional team to assure all aspects of a new product line’s compliance with all Regulatory, Clinical and QA technical, clinical and marketing requirements.


Key Responsibilities and Activities


The experienced and successful QA/RA pro in this role will work with a cross functional team to assure compliance with technical, clinical and marketing standards.


Develop and manage product line release plans and databases that include milestones and Timelines, and continuous maintenance records.


Liaise with cross-functional departments for preparation of documentation for submission of applications (MDD to MDR) to EU Notify Body.


With the VP to drive the clinical portion of the product line on patient recruitment strategies, operational feasibility and implementation of study objectives. Manage study documents, and maintain knowledge of the data, information, and formats required for regulatory applications.


Review and comment on data from contributing departments to ensure accurate and complete documents for inclusion in regulatory standards (UDI, IFU, Labeling, Packaging, Marketing) docs.


Serve as a key member of the matrix regulatory team; contribute to the generation and review of regulatory strategy documents, and generation of meeting agenda and minutes.


Independently manage interactions with clinical monitors, data management, safety, regulatory, and QA team members, both internally and externally in mitigations to the product release.


Work with departmental leaderships to maintain and continuously improve ISO 9001, et al.


Participate in the CAPA Review Board, internal and external audits, and training program. Make recommendations for corrective action necessary to ensure conformity with quality specifications.


Participate in cross-functional teams focused executing regulatory strategy.


Contribute to improvement/development of policies, procedures (RA SOPs), and best practices for regulatory submissions and approvals in multiple countries.


Assist in managing the regulatory information management system (RIMS) and support the Quality function with the implementation of a new eQMS and in updating the current processes within QMSR.

Required Education and Experience


BS or MS in a scientific discipline.


Minimum of 7-10 years of direct experience in medical device QA and RA including project leadership.


Strong knowledge of FDA 510 (k) and international regulatory requirements, GMP and GCP regulations, and Medical Device product requirements.


Experience with clinical data release operations.


Ability to find creative solutions to issues impacting timelines and budgets.


Working experience with CAPAs; exposure to audits is a plus.


Well organized with detail & deadline orientation.


Strong leadership, facilitation, and interpersonal skills, with the ability to interact with staff on all levels and thrive in a fast paced environment.


Excellent verbal & written communication skills.


Proven organizational skills and demonstrated problem-solving capabilities.


Able to work independently with minimal supervision.

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