- Directly support the product realization activities performed by Product Development and Research & Development Departments from a Regulatory Affairs standpoint.
- Support Marketing Material Development and Compliance to federal regulations, including website development, printable material, and speaking engagements.
- Manage unique device identifiers (UDI) submissions.
- Manage and lead regulatory submissions for TRG, Request for Designation (RFD), Pre-RFD, premarket notification/approvals, 510K, etc.
- Support development of validation protocols to verify compliance with regulatory requirements.
- Review validation protocols to verify compliance with regulatory requirements.
- Support new projects and product development.
- Support FMEA of new and existing products and procedures.
- Support and Collaborate with Product Commercialization RA team.
- Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB, other regulations (as appropriate), and industry standards.
- File and maintain records in accordance with standard operating procedures.
- Manage direct reports.
- Establish and monitor objective annual goals for direct reports.
- Conduct performance reviews and establish performance improvement plans as needed.
- Establish and execute continuing education strategy for department.
- Recruit, interview, and select personnel for hire.
- Attend/participate in offsite business meetings/conferences.
- Perform other related duties as assigned.
- Support cross functional Regulatory Affairs tasks when needed.
- Extensive knowledge of applicable government regulations.
- Ability to inform and educate department heads on regulations and policies that require compliance.
- Excellent attention to detail and organizational skills.
- Ability to multi-task
- Effective and verbal communication skills.
- Strong Leadership skills.
- Bachelor's degree in a biological science or related field required.
- Master's degree preferred.
- At least 5 years of quality and/or regulatory experience in an FDA regulated environment for HCT/Ps and/or medical devices (or related field) with progressive management responsibilities/experience.
-
Product Development Manager
3 days ago
USAA San Francisco, United States PermanentWhy USAA? · Let's do something that really matters. · At USAA, we have an important mission: facilitating the financial security of millions of U.S. military members and their families. Not all of our employees served in our nation's military, but we all share in the mission to g ...
-
Product Development Manager
3 days ago
USAA San Antonio, TX, United StatesWhy USAA?At USAA, we have an important mission: facilitating the financial security of millions of U.S. military members and their families. Not all of our employees served in our nation's military, but we all share in the mission to give back to those who did. As a dedicated Pro ...
-
Product Development Manager
3 days ago
USAA San Antonio, TX, United StatesWhy USAA?Let's do something that really matters. · At USAA, we have an important mission: facilitating the financial security of millions of U.S. military members and their families. Not all of our employees served in our nation's military, but we all share in the mission to giv ...
-
Product Manager
2 weeks ago
HOLT CAT San Antonio, United States Full timeJob Summary: · The Product Manager serves as the voice of the business in setting the vision for software product solutions through collaboration with key stakeholders in alignment with the organization's strategy and goals. This position manages the overall relationship between ...
-
Product Development Manager
3 days ago
USAA San Antonio, United States Full timeWhy USAA? · Let's do something that really matters. · At USAA, we have an important mission: facilitating the financial security of millions of U.S. military members and their families. Not all of our employees served in our nation's military, but we all share in the mission to g ...
-
Production Manager
2 weeks ago
Reyes Automotive Group San Antonio, United StatesJob Description · Job Description Description: · Job Title: Production Manager · Department: Production · Reports To: Plant Manager · Status: Exempt · Direct Reports: Directly manages assigned supervisory and professional staff and indirectly oversees hourly employees. · Job Typ ...
-
Production Manager
2 weeks ago
Reyes Automotive Group San Antonio, United StatesJob Description · Job DescriptionDescription:Job Title: Production Manager · Department: Production · Reports To: Plant Manager · Status: Exempt · Direct Reports: Directly manages assigned supervisory and professional staff and indirectly oversees hourly employees. · Job Type: ...
-
Production Manager
2 weeks ago
Extremity Care San Antonio, United StatesJob Description · Job DescriptionSalary: $75,000+ · ***Manager of Night Shifts. Hours currently being determined*** · ***This position will be at both 120 Chula Vista Drive and 12000 Network Boulevard in San Antonio, TX.*** · Purpose: · The Production Supervisor is responsible f ...
-
Production Manager
1 day ago
Winland Foods, Inc. San Antonio, United StatesThe Production manager provides overall leadership for manufacturing departments in the areas of safety, productivity, quality, cost, equipment, and engagement. Through subordinates, monitors, and evaluates the production process and recommends methods to optimize product yields, ...
-
Production Manager
2 weeks ago
J.D. COLLISION EXPRESS LLC San Antonio, United StatesJob Description · Job DescriptionA Production Manager is responsible for overseeing the production process, scheduling work, maintaining quality control, complying with all OSHA and EPA regulations and verifying parts procurement. This position requires leadership skills, investm ...
-
Production Manager
2 weeks ago
MALDONADO NURSERY AND LANDSCAPING INC San Antonio, United StatesJob Details · Job Location · Maldonado San Antonio - San Antonio, TX · Description · Maldonado Nursery & Landscaping, Inc. is the landscape partner of choice. We're devoted to providing top-quality landscape services to both commercial and residential clients at competitive pr ...
-
Digital Product Manager
3 weeks ago
Apex Systems San Antonio, United StatesAs a team member, supports and serves as a resource to the achievement of team/organization goals. The candidate will assist in the management and support of the end-to-end performance of digital channels (web, mobile web, and mobile applications). This may include helping in req ...
-
Development Product Owner I
3 days ago
USAA San Antonio, United StatesWhy USAA? · Let's do something that really matters. · At USAA, we have an important mission: facilitating the financial security of millions of U.S. military members and their families. Not all of our employees served in our nation's military, but we all share in the mission to g ...
-
Development Manager
2 weeks ago
Merit Commercial Real Estate San Antonio, United StatesJob Description · Job DescriptionPosition Summary: · A Development Manager at Merit Commercial Real Estate is responsible for overall project execution and oversight. Project execution includes due diligence, entitlements, programming, design, budgeting, proformas, and building t ...
-
Development Manager
20 hours ago
Merit Commercial Real Estate LLC San Antonio, United StatesPosition Summary: · A Development Manager at Merit Commercial Real Estate is responsible for overall project execution and oversight. Project execution includes due diligence, entitlements, programming, design, budgeting, proformas, and building turnover. · Key Performance Outc ...
-
Product Management Principal
3 weeks ago
United Services Automobile Association San Antonio, United States Full timeWhy USAA? · Let's do something that really matters. · At USAA, we have an important mission: facilitating the financial security of millions of U.S. military members and their families. Not all of our employees served in our nation's military, but we all share in the mission to g ...
-
Production Manager Bakery
1 day ago
SusieCakes Bakery San Antonio, United StatesLeads the teams by motivating, training, and developing the culinary team members in the production category through adherence to recipes and standard operating procedures including, but not limited to, cakes, cookies, pies, bars, puddings, buttercre Production Manager, Bakery, M ...
-
Technical Product Manager
1 week ago
Raft Company Website San Antonio, United StatesJob Description · Job DescriptionThis is a U.S. based position. All of the programs we support require U.S. citizenship to be eligible for employment. All work must be conducted within the continental U.S. · Who we are: · Raft ) is a customer-obsessed non-traditional small busine ...
-
Production Manager Bakery
2 days ago
SusieCakes San Antonio, United StatesJob Description · Job DescriptionNew bakery location opening in San Antonio in the fall Our company is excited to expand our foot print in the market with our scratch made homestyle baked goods. · We are seeking a Production Manager that has a passion for the baking, leading a te ...
-
Technical Product Manager
3 days ago
Raft San Antonio, United StatesThis is a U.S. based position. All of the programs we support require · U.S. citizenship to be eligible for employment. All work must be conducted within the continental U.S. · Who we are: · Raft ( ) is a customer-obsessed non-traditional small business with a purposeful focu ...
Regulatory Affairs Manager-Product Development - San Antonio, United States - Extremity Care
Description
Job Description
Job DescriptionSalary: $90KPurpose:
The Regulatory Affairs Manager is responsible for managing the regulatory affairs for the product development department and functions to ensure regulatory compliance of quality management system, product realization and marketing materials.
Duties & Responsibilities:
Skills & Abilities:
Education & Experience: