$140K — $160K *
MEDICAL DEVICE Senior Regulatory Manager - Remote/telework
Work independently and as part of the RA Management Team on RA duties, and delegate, as applicable, processes and roles outlined below.
You are responsible for
Lead Regulatory Group or Project teams for Regulatory Projects with Business Unit Impact, to include the direct or indirect management of people, the development of executable Quality Plans, coordination with partnering functions/departments/resources and the management of the associated schedule and budget.
Creation and execution of Regulatory Strategies and Plans for assigned products in the Domestic, Mature, and Emerging Markets, including assessments of the regulatory impact of changes to design, materials, labeling, software, and suppliers.
Manages assigned Regulatory Affairs Budget.
Process Owner for Regulatory QSPs and WIs.
Develops subordinate Regulatory personnel and reviews assigned project outputs.
Conducts Biannual Review of Regulatory QSPs and WIs.
New Product Licensing and Registration submissions in the Domestic and Mature Markets (US, EU, CAN, AU)
Create and/or lift Regulatory Restrictions based on the Regulatory status of assigned products, as needed.
German Reimbursement submissions
Provides document support to the Emerging Markets team for international product registration
Tracks pending domestic and global regulatory changes, develops and executes quality plans to minimize impact to the Business Unit.
Maintains expertise in domestic and foreign regulations and standards, with a focus on assigned products and regional focus on the US (FDA), EU (MDD), CA (Health Canada), and AU (TGA).
Provides Regulatory Training to business units on regulations and standards as they apply to assigned products / business units.
Conducts Regulatory Intelligence Analysis on specific assigned regions or content and briefs the business unit management teams on results.
To succeed in this role, you should have the following skills and experience
B.S. or equivalent in Engineering, Life sciences, or other similar technical field. Master’s degree preferred. RAC preferred.
Minimum of 10 years of experience within Medical Device industry. Duties and tasks reflect variety and complexity.
Must have experience in:
Supporting and providing regulatory expertise to assigned product development projects from technical approach to post marketing phase
Creating and executing Regulatory Strategies and Plans for assigned products in the domestic and international markets, including assessments of the regulatory impact of changes to design, materials, labeling, software, and suppliers
Preparing and submitting 510(k)'s, IDE's and other product submissions according to FDA guidelines
Creating European Technical File and Declaration of Conformity documents (MDD, R&TTE, LVD, RoHS, etc.) and Canadian licensing submissions according to international guidelines
Reviewing and approving product labeling plans, labeling, and marketing communications
Supporting the international regulatory team with inputs, as needed, into the registration packages they prepare
Supporting internal and external quality audits; participate as a member of PMRA and CAPA teams for Corrective and Preventative Actions
Base Salary - USD $140,000 to $162,000
Seniority Level - Mid-Senior
Minimum Education - Bachelor's Degree
Willingness to Travel - Never
Valid through: 12/17/2021
$80K — $100K *
5 days ago