Clinical Regulatory Specialist Jobs in Massachusetts

Strong relationship management, analytical, and interpersonal skills required to quickly gain confidence of stakeholders and team members required.

Strong organizational skills enabling the management of multiple, simultaneous submissions often with different team members and different timelines.

Formal project management training optimal; practical project management skills and recent application required.

Manages communications and activities with third-party publishers and regulatory vendors.

Manages and indexes archives of regulatory submissions; manages and files regulatory correspondence.

Familiarity with Veeva Vault – RIM, Sharepoint, and publishing software strongly preferred. Sophisticated MS-Office skills required.

Familiarity with medical device requirements in the US and/or EU (Class III experience is a plus)

Review QMS and product changes for compliance to regulatory requirements

Ensure compliance with corporate and regulatory requirements (e.g., GCP and ISO 14155).

Knowledge of medical device US and EU regulations, standards, and guidance documents (21 CFR 820, MDR, ISO 13585, ISO 14971, etc.)

2+ years previous experience in medical device product development or related field. Regulatory affairs, clinical affairs, or clinical research experience required.

Must be able to manage or support multiple projects.