Vice President Regulatory Affairs
2 weeks ago
Vice President Regulatory Affairs (Medical Device) - ONSITE in Bay Area
Our esteemed client, a inovative and growing medical device company specializing in the manufacturing of implantable medical devices. They are looking for a Vice President Regulatory Affairs to spearhead regulatory strategies that will shape the future of healthcare and continue building out their Regulatory Department.
Key Responsibilities:
Develop and implement global regulatory strategies for the successful approval and commercialization of implantable devices in the US and international markets.
Oversee the preparation and submission of regulatory dossiers for FDA and OUS regulatory approvals, including IDE, 510(k), PMA, and CE Mark applications.
Act as the primary point of contact with regulatory authorities, ensuring open communication and successful interactions during the review process.
Collaborate cross-functionally with R&D, Quality Assurance, Clinical Affairs, and other departments to align regulatory objectives with business goals.
Stay abreast of evolving regulatory requirements and industry trends, providing guidance to the executive team and ensuring the company's ongoing compliance with global regulations.
Experience with implantable devices and Software experience/Cybersecurity would be a plus.
Build and develop a proactive, versatile and cross functional regulatory team.
Qualifications:
A minimum of 12 years of experience in regulatory affairs within the medical device industry.
Proven track record of successful regulatory submissions and approvals in both the US (510k, De Novo, PMA) and international markets (CE Mark and OUS submissions).
Strong leadership and management skills, with experience leading regulatory teams and driving results in a fast-paced environment.
Deep knowledge of the full product lifecycle for Medical Devices.
In-depth knowledge of global medical device regulations, standards, and guidelines, and the ability to interpret and apply them effectively.
Excellent communication and interpersonal skills, with the ability to build relationships with regulatory authorities and cross-functional teams.
A bachelor's degree in a related field (Engineering); an advanced degree is preferred.
If you would like to learn more about this Vice President Regulatory Affairs opportunity and have the desire to build and develop a regulatory team, apply today or contact me directly on the following:
wjlynch@barringtonjames.com
#J-18808-Ljbffr
-
Vice President
Found in: Appcast Linkedin GBL C2 - 1 day ago
Los Angeles, United States Selby Jennings Full timeSummary: An established Middle-Market Private Equity firm is looking to expand their team with a Private Equity Vice President! They are located in Los Angeles, CA and focus on a wide variety of industries. This is a very team-focused, collaborative firm that provides an environment for growth. As a Vice President, you will play an integral role in all...
-
Vice President
2 days ago
Los Angeles, United States Selby Jennings Full timeSummary: An established Middle-Market Private Equity firm is looking to expand their team with a Private Equity Vice President! They are located in Los Angeles, CA and focus on a wide variety of industries. This is a very team-focused, collaborative firm that provides an environment for growth. As a Vice President, you will play an integral role in all...
-
Vice President
2 days ago
Los Angeles, United States Selby Jennings Full timeSummary: An established Middle-Market Private Equity firm is looking to expand their team with a Private Equity Vice President! They are located in Los Angeles, CA and focus on a wide variety of industries. This is a very team-focused, collaborative firm that provides an environment for growth. As a Vice President, you will play an integral role in all...
-
Vice President
3 days ago
Los Angeles, United States Selby Jennings Full timeSummary: An established Middle-Market Private Equity firm is looking to expand their team with a Private Equity Vice President! They are located in Los Angeles, CA and focus on a wide variety of industries. This is a very team-focused, collaborative firm that provides an environment for growth. As a Vice President, you will play an integral role in all...
-
Director of Regulatory Strategy
2 weeks ago
Los Angeles, United States Cypress HCM Full timeThe role involves providing global regulatory oversight and project leadership for assigned development products, reporting directly to the Vice President of Regulatory Affairs. The incumbent will contribute to and execute regulatory strategies to facilitate global product development, oversee regulatory communications with health authorities, and ensure...
-
Assistant Vice President
Found in: Jooble US O C2 - 4 days ago
Los Angeles, CA, United States Nike Communications, Inc. Full timeSanta Monica, CA 90411 posted 04/23/2024 More... front runner Assistant Vice President - Workers Compensation Crawford & Company Brea, CA 92821 posted yesterday More... front runner Assistant Vice President, Tax Operations Consultative Search Group Los Angeles, CA 90001 posted yesterday More... quick apply Assistant Vice President - Property & Casualty...
-
Vice President of Hospital Finance
21 hours ago
Los Angeles, United States Clinical Management Consultants Full timeA hospital in the Los Angeles area is in search of a new Vice President of Hospital Finance. This hospital has made a huge positive impact on the population it serves. It is known for its high-touch care and quality services they have been providing Vice President, Finance, Hospital, President, Management, Staffing
-
Vice President Investment Banking
Found in: Appcast Linkedin GBL C2 - 6 days ago
Los Angeles, United States Selby Jennings Full timeTitle: Investment Banking Vice President Company Summary: We are currently working with a top-tier Middle Market investment bank out of Los Angeles, CA who is looking to add talent to their busy Beauty and Wellness team. This opportunity will allow you to join an execution driven team, work directly with senior leadership, and work with one of the most...
-
Vice President Investment Banking
6 days ago
Los Angeles, United States Selby Jennings Full timeTitle: Investment Banking Vice President Company Summary: We are currently working with a top-tier Middle Market investment bank out of Los Angeles, CA who is looking to add talent to their busy Beauty and Wellness team. This opportunity will allow you to join an execution driven team, work directly with senior leadership, and work with one of the most...
-
Regulatory Affairs Specialist
1 week ago
Los Angeles, United States BioTalent Full timePosition Summary The primary responsibility of the Regulatory Affairs Specialist is to manage and perform regulatory submissions for local and worldwide regulatory agencies. The RAS is also responsible for ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for our client's product...
-
Los Angeles, United States J. Paul Getty Full timeThe J. Paul Getty Trust, one of the world's most influential cultural and philanthropic institutions dedicated to advancing access to visual arts, is currently seeking a Vice President of Communications and Community Engagement (VP). Reporting to and Communications, Vice President, Engagement, Communication, President, International, Business Services
-
Regulatory Affairs Specialist
2 weeks ago
Los Angeles, United States PureTek Full timeJob Description Job Description PureTek is a dynamic and innovative company specializing in developing and manufacturing pharmaceutical and cosmetic products. With a commitment to quality, safety, and regulatory compliance, we strive to deliver products that enhance the well-being and beauty of our consumers. Join our team and contribute to our mission of...
-
AD/Director Regulatory Affairs
2 weeks ago
Los Angeles, United States Meet Full timeMeets clinical-stage biopharmaceutical client based in the Bay Area is seeking a highly motivated individual to join their growing regulatory affairs group. The Associate Director / Director, Regulatory Affairs will work closely with the Regulatory Affairs team and other departments to develop and implement regulatory strategies for the company's rare...
-
Regulatory Affairs Consultant
1 week ago
Los Angeles, United States Meet Full timeThe Company Our client is a California Biotech working on immunology and oncology products. The Role They are looking for a Regulatory Affairs contractor for 10 hrs a week, who will be responsible for aiding and working in a fast pace accelerated environment. This is a remote 6 month contract position, looking for 10 hr/week. Responsibilities: Assist in...
-
Regulatory Affairs Specialist
1 week ago
Los Angeles, United States PureTek Corp Full timeJob DescriptionJob Description PureTek is a dynamic and innovative company specializing in developing and manufacturing pharmaceutical and cosmetic products. With a commitment to quality, safety, and regulatory compliance, we strive to deliver products that enhance the well-being and beauty of our consumers. Join our team and contribute to our mission of...
-
Senior Regulatory Affairs Specialist
2 weeks ago
Los Angeles, United States Barrington James Full timeSenior Regulatory Affairs Specialist (Medical Devices) - Hybrid (Bay Area) Our client is a growing Imaging Medical Device company that is making a meaningful impact on patient lives. They are looking for a Senior Regulatory Affairs Specialist with a track record of bringing imaging devices to market. Responsibilities: Prepare and submit regulatory...
-
Vice President of Marketing
4 days ago
Los Angeles, United States Pailin Group Psc Full timeOur premier health care client has an immediate opening in their Valencia, CA corporate office for a Vice President of Marketing. The Vice President of Marketing will be responsible for all corporate marketing and product management activities, the analysis of existing marketing strategies, the design and implementation of new marketing strategies, building...
-
Regulatory Affairs Coordinator
6 days ago
Los Angeles, United States ProKatchers Full timeJob Title: Regulatory Affairs Coordinator/Regulatory Windchill Coordinator Location: 91342, Los Angeles, California, United States Duration: 06 Month Job Description: This position is a shared role providing business support to the Medical Device division and collaborating with the Supply Chain Group, Regulatory Affairs, Clinical, and Customer Service. ...
-
Regulatory Affairs Coordinator
Found in: Appcast US C2 - 1 week ago
Los Angeles, United States ProKatchers LLC Full timeJob Title: Regulatory Affairs Coordinator/Regulatory Windchill CoordinatorLocation: 91342, Los Angeles, California, United StatesDuration: 06 MonthJob Description:This position is a shared role providing business support to the Medical Device division and collaborating with the Supply Chain Group, Regulatory Affairs, Clinical, and Customer Service. Person...
-
Regulatory Affairs Coordinator
Found in: Appcast Linkedin GBL C2 - 1 week ago
Los Angeles, United States ProKatchers LLC Full timeJob Title: Regulatory Affairs Coordinator/Regulatory Windchill CoordinatorLocation: 91342, Los Angeles, California, United StatesDuration: 06 MonthJob Description:This position is a shared role providing business support to the Medical Device division and collaborating with the Supply Chain Group, Regulatory Affairs, Clinical, and Customer Service. Person...