Regulatory Affairs Director
4 days ago
Planet Pharma is seeking a highly experienced Regulatory Affairs professional to lead our regulatory strategies, submissions, and compliance initiatives. As a key member of our team, you will contribute to the company's growth and reputation within the medical device industry.
Key Responsibilities- Regulatory Strategy Development
- Oversee the development and execution of regulatory strategies for new product development, including classification, pathway selection, and global market access.
- Team Leadership
- Provide leadership for the team, including performance management, talent development, succession planning, and employee development.
- Collaboration and Partnership
- Partner with cross-functional teams, including R&D, Clinical, Quality, and Design Assurance, to ensure alignment on regulatory strategy, submissions, and compliance activities.
- Regulatory Document Preparation and Submission
- Oversee the preparation, review, and submission of regulatory documents to regulatory authorities and international agencies, ensuring compliance with relevant regulations and guidelines.
- Regulatory Agency Interaction
- Manage negotiation and maintain interaction with regulatory authorities worldwide during the development and review process to ensure submission approval and clearances.
- Risk Management and Compliance
- Collaborate with cross-functional teams to assess and manage risks associated with products, processes, and regulatory changes. Implement risk mitigation strategies as needed.
- Regulatory Audit and Inspection Support
- Ensure preparedness and support of regulatory agency audits, inspections, and interactions, including facilitating document requests, coordinating responses, and addressing findings.
- Regulatory Due Diligence and Integration
- Provide regulatory due diligence and integration strategies for mergers, acquisitions, and partnerships to ensure smooth transitions and compliance, as needed.
- Regulatory File Maintenance
- Maintain organized and up-to-date regulatory files, records, and documentation, ensuring accessibility and accuracy for internal and external stakeholders.
- Education
- Bachelor's degree in science, engineering, or a related field of study.
- Experience
- 7-10 years of related Medical Device Regulatory Affairs experience, with experience in Class I and II devices, and Class III experience preferred.
- Leadership Experience
- 5-7 years of leadership experience, including the proven ability to lead and motivate others.
- Certifications
- RAC certification is a plus.
Planet Pharma offers a competitive compensation package, commensurate with level of experience.
-
Clinical Affairs Director
4 days ago
Morrisville, North Carolina, United States Teleflex, Inc. Full timeJob SummaryWe are seeking a highly skilled Clinical Affairs Manager to join our team at Teleflex, Inc.Key ResponsibilitiesProvide clinical expertise and support to internal stakeholders, including sales teams, regulatory, engineering, and marketing departments.Collaborate with cross-functional teams to ensure safe and effective use of our products.Develop...
-
Executive Director
7 days ago
Morrisville, North Carolina, United States Morrisville Chamber of Commerce Full timeJob SummaryThe Morrisville Chamber of Commerce is seeking a highly skilled and experienced Executive Director to lead our organization in achieving its mission of promoting the growth and vitality of the Morrisville community. As the chief executive officer, you will be responsible for directing the strategic planning, program of work, community leadership,...
-
Pharmaceutical Quality Assurance Director
5 days ago
Morrisville, North Carolina, United States SynergenX Full timeJob DescriptionAt SynergenX, we are seeking a highly skilled Pharmaceutical Quality Assurance Director to oversee and manage all quality assurance activities for our organization. This individual will be responsible for ensuring compliance with FDA regulations, cGMP, and internal policies and procedures.Key Responsibilities:Regulatory Compliance:Ensure the...
-
Teacher for Childcare Center
2 weeks ago
Morrisville, North Carolina, United States Primrose School at The Park Full timeJob OverviewWe are seeking a highly skilled and dedicated Teacher to join our team at Primrose School at The Park. As a key member of our staff, you will play a vital role in providing a nurturing and educational environment for our young students.Key ResponsibilitiesClassroom Management: Supervise and enforce daily class routines to ensure a safe and...
-
Childcare Professional
2 weeks ago
Morrisville, North Carolina, United States Primrose School at The Park Full timeJob OverviewWe are seeking a dedicated and experienced Early Childhood Educator to join our team at Primrose School at The Park. As a key member of our staff, you will play a vital role in providing a high-quality educational experience for our young students.Key ResponsibilitiesClassroom Management: Supervise and enforce daily class routines to ensure a...
-
Senior Vice President, Oncology Strategy
3 weeks ago
Morrisville, North Carolina, United States Thermo Fisher Scientific Full timeWork Schedule Standard (Mon-Fri) Environmental Conditions Office Job Overview At Thermo Fisher Scientific, we empower our teams to engage in meaningful work that drives positive change globally. Join us in fulfilling our Mission - enabling our clients to enhance global health, safety, and environmental standards. We equip our professionals with the necessary...
-
Senior Manager Regulatory Affairs
1 day ago
Morrisville, United States Planet Pharma Full timePosition: Senior Manager, Regulatory AffairsLocation: Morrisville, NC (Onsite 3 days a week, Tuesday-Thursday)Salary: Base salary of $160K-$170K with a potential 16% bonus and eligibility for long-term incentives (RSUs)Relocation: Candidates willing to relocate will be consideredOverview:We are seeking an experienced Senior Manager of Regulatory Affairs to...
-
Senior Manager Regulatory Affairs
1 day ago
Morrisville, United States Planet Pharma Full timePosition: Senior Manager, Regulatory AffairsLocation: Morrisville, NC (Onsite 3 days a week, Tuesday-Thursday)Salary: Base salary of $160K-$170K with a potential 16% bonus and eligibility for long-term incentives (RSUs)Relocation: Candidates willing to relocate will be consideredOverview:We are seeking an experienced Senior Manager of Regulatory Affairs to...
-
Sr. Manager Regulatory Affairs
3 weeks ago
Morrisville, United States Planet Pharma Full time614265Our client, a leading Medical Device company in Morrisville, NC, is looking for a Sr. Manager of Regulatory Affairs to lead regulatory strategies, submissions, and compliance initiatives, contributing directly to the company's growth and reputation within the medical device industry.Skills:Bachelor’s degree in science, engineering, or related field...
-
Sr. Manager Regulatory Affairs
4 weeks ago
Morrisville, United States Planet Pharma Full time614265Our client, a leading Medical Device company in Morrisville, NC, is looking for a Sr. Manager of Regulatory Affairs to lead regulatory strategies, submissions, and compliance initiatives, contributing directly to the company's growth and reputation within the medical device industry.Skills:Bachelor’s degree in science, engineering, or related field...
-
Sr. Regulatory Affairs Specialist
1 month ago
Morrisville, United States tapwage Full timeExpected Travel: Up to 10%Requisition ID: 10689About Teleflex IncorporatedAs a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people's lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia,...
-
Clinical Affairs Manager
3 days ago
Morrisville, United States Teleflex Full timeJob SummaryThe Clinical Affairs Manager will provide clinical expertise and support to various departments within Teleflex, including clinical sales specialists, sales teams, regulatory, engineering, marketing, and other corporate departments. The primary focus will be on the safe and effective use of the Interventional product portfolio, with a particular...
-
Clinical Affairs Manager
4 months ago
Morrisville, United States Teleflex Full timePosition Summary The Clinical Affairs Manager provides clinical expertise, insight and support to clinical end-users, clinical sales specialist, sales team, Regulatory, Engineering, marketing and other corporate departments on safe and effective use of the Interventional product portfolio with primary emphasis on the Coronary franchise. Supports the...
-
Oncology Medical Liaison, Carolinas
3 weeks ago
Morrisville, North Carolina, United States Deciphera Pharmaceuticals Full timePosition OverviewDeciphera Pharmaceuticals is in search of a dedicated Medical Science Liaison (MSL) who will serve as a field-based scientific and clinical expert, reporting directly to the Senior Director of Medical Affairs within the Medical Affairs department.Key ResponsibilitiesThe MSL will:Engage with Healthcare Providers (HCPs) in both academic and...
-
Technical Writer
2 months ago
Morrisville, United States Insight Global Full timeWe are seeking a detail-oriented and experienced Technical Writer to join our team. As a Technical Writer, you will play a crucial role in creating clear and comprehensive documentation that translates complex scientific and technical information into user-friendly materials. Your primary responsibility will be to produce high-quality documents such as...
-
Technical Writer
2 months ago
Morrisville, United States Insight Global Full timeWe are seeking a detail-oriented and experienced Technical Writer to join our team. As a Technical Writer, you will play a crucial role in creating clear and comprehensive documentation that translates complex scientific and technical information into user-friendly materials. Your primary responsibility will be to produce high-quality documents such as...
-
Medical Science Liaison, Carolinas
4 weeks ago
Morrisville, United States Deciphera Pharmaceuticals Full timeJob DescriptionJob DescriptionCompany DescriptionDeciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of...
-
Associate Director, Project Management
3 months ago
Morrisville, United States WEP Clinical Full timeJob DescriptionJob DescriptionSalary: Are you a professional with strong initiative and excellent problem-solving skills? Do you aspire to make a meaningful impact in the pharmaceutical industry, particularly in overseeing and executing critical projects? If so, we have an exciting opportunity for you! Join our team at WEP Clinical as an Associate Director...
-
Senior Director-Enterprise Data
4 weeks ago
Morrisville, United States Alliance Full timeThe Senior Director of Enterprise Data is responsible to oversee the design, build, operational management, and maintenance of our Enterprise Data Warehouse, Data Interoperability, and Data Operations platforms and teams. The Senior Director of Enterprise Data will ensure that our data infrastructure is robust, scalable, and aligned with the strategic goals...
-
Human Resource Director
2 months ago
Morrisville, United States Lamoille Health Partners Full timeJob DescriptionJob DescriptionJOB SUMMARY: The Human Resource Director will plan, lead, direct, develop, and coordinate the policies, activities, and staff of the Human Resource (HR) department, ensuring legal compliance and implementation of the organization's mission and talent strategy.SUPERVISORY RESPONSIBILITIES:Recruits, interviews, hires, and...
-
Director of Environmental Health
2 weeks ago
Morrisville, United States Brady Services Full timeJob Details Raleigh Office - Morrisville, NC Full Time 4 Year Degree Not Specified Day/First Shift OtherDescription Are you a Director of Environmental, Health & Safety searching for new experiences? As a leading Trane® independent office, Brady brings efficient, reliable, and secure building solutions throughout central and eastern North Carolina. We...
-
Safety Director
2 weeks ago
Morrisville, Pennsylvania, United States Gelest Full timeAbout GelestGelest is a leading manufacturer and supplier of advanced materials and chemicals, recognized globally for its innovative approach to materials science and technology.Job SummaryWe are seeking a highly experienced and skilled Safety Director to join our team at Gelest. As a key member of our organization, you will be responsible for developing,...
-
Senior Director-Enterprise Data
4 weeks ago
Morrisville, United States Alliance Full timeThe Senior Director of Enterprise Data is responsible to oversee the design, build, operational management, and maintenance of our Enterprise Data Warehouse, Data Interoperability, and Data Operations platforms and teams. The Senior Director of Enterprise Data will ensure that our data infrastructure is robust, scalable, and aligned with the strategic goals...
-
Senior Director-Enterprise Data
3 weeks ago
Morrisville, United States Alliance Full timeThe Senior Director of Enterprise Data is responsible to oversee the design, build, operational management, and maintenance of our Enterprise Data Warehouse, Data Interoperability, and Data Operations platforms and teams. The Senior Director of Enterprise Data will ensure that our data infrastructure is robust, scalable, and aligned with the strategic goals...
-
Clinical Development Operations Director
4 days ago
Morrisville, North Carolina, United States Lifelancer Full timeAbout the RoleWe are seeking an experienced Clinical Development Operations Director to join our team at Lifelancer. As a key member of our organization, you will be responsible for leading our Clinical Development Operations team and driving the success of our clients.Key ResponsibilitiesLead and manage a team of Clinical Development Operations...
-
Associate Director Ops
5 days ago
Morrisville, United States Life Technologies (Thermo Fisher Scientific) Full timeWork ScheduleStandard (Mon-Fri)Environmental ConditionsOffice Job Description Oversees day to day operations of one or more projects and directs, mentors and supports operations managers and other members of their project teams. Ensures that services are provided in accordance with client and PPD Medical Communications' policies and procedures and...