The Senior Manager Regulatory Affairs (NIPT) will be responsible for:
- Participates in establishing and implementing regulatory policies and procedures that affects own area(s).
- Provides regulatory guidance associated with the development, support, and manufacturing of the Company’s
- medical device products.
- Primarily responsible for the development and implementation of Regulatory strategies and plans to support the
- timely introduction of new products and the preparation and review of government submissions to achieve timely
- and cost effective clearance/approval. Fully accountable for managing the information provided for maintaining
- registrations and listings.
- Reviews and approves product labeling to ensure conformance with Regulatory requirements and/or approved
- product claims.
- Primary regulatory contact with affiliates to achieve registration.
- Partners with QC/QA and manufacturing as a participant in the change control processes and associated
- validations and re-validations.
- Works on complex issues; develops solutions.
- Position has HR responsiblity for direct and indirect reports which includes hiring/firing decisions, interviewing,
- selection, performance feedback, discipline, pay decisions and handling employee grievances/complaints.
- Directs the maintenance of product and process regulatory compliance.
- Bachelor’s Degree or equivalent, Master's Degree/PhD preferred
- 9 years regulatory affairs experience in the medical product industry
- 25% based on business needs
Roche is an equal opportunity employer.Regulatory Affairs, Regulatory Affairs > General Regulatory Affairs