Regulatory Affairs Specialist
13 hours ago
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.
Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team in the Diabetes Care Division. As a Regulatory Affairs Specialist, you will be responsible for developing and implementing regulatory strategies for product development and planning throughout the product lifecycle.
Key Responsibilities- Develop global regulatory strategies for product development and planning throughout the product lifecycle.
- Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions.
- Provide technical leadership and strategic input on complex issues and to business units.
- Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
- Create project plans and timelines.
- Lead functional groups in the development of relevant data to complete a regulatory submission.
- Write and edit technical documents.
- Administer/meet regulatory requirements to achieve excellent compliance status with no enforcement actions.
- Negotiate with regulatory authorities during the development and review process to ensure submission approval.
- Review and approve labeling to ensure compliance.
- Monitor emerging issues and identify solutions.
- Negotiate internally and externally with regulatory agencies.
- Evaluate regulatory risks of corporate policies.
- Oversee processes involved with maintaining annual licenses, registrations, listings and patent information.
- Ensure compliance with product post-marketing approval requirements.
- Develop, implement and manage appropriate SOPs and systems to track and manage product-associated events.
- Actively contribute to the development and functioning of the crisis/issue management program
- Analyze product-associated problems and develop proposals for solutions.
- Oversee system to ensure that product safety issues and product-associated events are reported to regulatory agencies.
- Provide regulatory input for product recalls and recall communications.
- Bachelor's Degree in Scientific discipline e.g. Chemistry, life Sciences, Biology (or equivalent vocational qualifications)
- Experienced in regulatory submissions for Pharmaceutical, in vitro diagnostic devices and/or medical devices.
- Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC).
- 5 years' experience working with Class II, Class III medical devices and/or biologics/drugs.
- Regulatory Affairs Certification (RAC) is a plus.
- Experience with either 510(k) applications, PMA supplements, NDA, BLA, US device regulations, US biologics regulations, US drug regulations or with EU and other international medical device regulations and submissions.
- Familiar with relevant regulatory requirements for medical devices, drugs and/or biologics including Quality Systems standards, clinical investigations, ICH guidelines.
- Experience with word processing, spreadsheet and presentation graphic software packages.
- Experience working in a broader enterprise/cross-division business unit model.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Ability to leverage and/or engage others to accomplish projects.
- Ability to identify, solve problems, and work independently with little oversight.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Multitasks, prioritizes, and meets deadlines in a timely manner.
- Strong organizational and follow-up skills, as well as attention to detail.
- Ability to travel approximately 5%, including international travel.
This is an exciting opportunity to join our team and contribute to the development and implementation of regulatory strategies for product development and planning throughout the product lifecycle. As a Regulatory Affairs Specialist, you will have the opportunity to work on a variety of projects and develop your skills and expertise in regulatory affairs.
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced Regulatory Affairs Specialist looking for a new challenge, we encourage you to apply.
Abbott is an Equal Opportunity Employer, committed to employee diversity. We are proud to be a company that values and celebrates diversity and inclusion.
Apply now to join our team and take the first step towards a rewarding career in regulatory affairs.
-
Regulatory Affairs Specialist
2 weeks ago
Alameda, California, United States Abbott Laboratories Full timeAbout the RoleAbbott Laboratories, a leading global healthcare company, is seeking a highly skilled Regulatory Affairs Manager to join our Diabetes Care Division in Alameda, CA. As a key member of our team, you will play a critical role in ensuring the efficient and compliant business processes and environment for our digital health technology products.Key...
-
APAC Regulatory Affairs Specialist II
2 weeks ago
Alameda, California, United States Intellectt Inc Full timeJob Description**Role:** APAC Regulatory Affairs Specialist II**Location:** Onsite**Duration:** 12 Months**Education:** Bachelor's degree**Experience Background:** APAC regulatory submissions in Medical Devices or Pharmaceutical industries.**Job Description (Expectation):Responsible for regulatory activities, including product registrations, regulatory...
-
Regulatory Affairs Expert
4 weeks ago
Alameda, California, United States Abbott Laboratories company Full timeJoin Abbott LaboratoriesAt Abbott, you will engage in meaningful work that contributes to your personal growth and professional development, while also caring for your well-being and that of your family.Benefits Include:Opportunities for career advancement within a global organization.Comprehensive medical coverage for employees through the Health Investment...
-
Lead Specialist in Regulatory Affairs Operations
4 weeks ago
Alameda, California, United States Abbott Full timeAbout Abbott:Abbott is a prominent player in the global healthcare sector, dedicated to enhancing the quality of life for individuals at every stage. Our extensive range of transformative technologies encompasses diagnostics, medical devices, nutritionals, and branded generic medicines. With a workforce of 114,000 professionals, we serve communities in over...
-
Regulatory Affairs Director
5 days ago
Alameda, California, United States Scribe Therapeutics Full timeJob Title: Associate Director/Director, Regulatory AffairsScribe Therapeutics is a molecular engineering company focused on creating innovative in vivo therapies that address the root causes of disease. Our team is dedicated to developing best-in-class CRISPR-based genetic medicines.Job SummaryWe are seeking a highly skilled and motivated individual to join...
-
Senior Regulatory Affairs Consultant
4 weeks ago
Alameda, California, United States Abbott Full timeCompany Overview:Abbott is a leading global healthcare organization dedicated to enhancing the quality of life for individuals at every stage of their health journey. Our extensive range of innovative technologies covers various healthcare sectors, including diagnostics, medical devices, nutritionals, and branded generic medicines. With a workforce of...
-
Regulatory Affairs Expert for APAC Region
4 weeks ago
Alameda, California, United States Abbott Full timeAbout AbbottAbbott is a leading global healthcare organization dedicated to enhancing the quality of life for individuals at every stage of their health journey. Our extensive portfolio includes transformative technologies across various sectors, including diagnostics, medical devices, nutritionals, and branded generic medications. With a workforce of...
-
Senior Regulatory Affairs Associate
4 weeks ago
Alameda, California, United States Abbott Laboratories company Full timeJoin Abbott LaboratoriesAt Abbott, we empower you to engage in meaningful work, advance your career, and prioritize your well-being and that of your family. We encourage you to be your authentic self and enjoy a fulfilling life.What We Offer:Career advancement opportunities within a global organization.Comprehensive medical coverage for employees through our...
-
Advanced Regulatory Affairs Expert
4 weeks ago
Alameda, California, United States Abbott Laboratories company Full timeAbout Abbott LaboratoriesAbbott Laboratories is a leading global healthcare organization dedicated to enhancing the quality of life for individuals at every stage of their journey. Our extensive range of innovative technologies encompasses diagnostics, medical devices, nutritional products, and branded generic medications. With a workforce of 114,000...
-
Regulatory Affairs Director
3 weeks ago
Alameda, California, United States Abbott Full timeAbout AbbottAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160...
-
Lead Regulatory Affairs Specialist
4 weeks ago
Alameda, California, United States Cynet Systems Full timePosition Overview:Compensation Range: $55.49/hr - $60.49/hrKey Responsibilities:Oversee regulatory functions, including product approvals and impact evaluations.Comprehend and convey country-specific regulations to internal teams, such as product management, engineering, and labeling, for effective product registration and modification strategies.Engage in...
-
Regulatory Affairs Director
2 weeks ago
Alameda, California, United States Abbott Laboratories Full timeAbout Abbott LaboratoriesAt Abbott Laboratories, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to:Career development with an international company where you can grow the career you dream of.Free medical coverage for employees* via the Health Investment Plan (HIP)...
-
Regulatory Affairs Manager
1 day ago
Alameda, California, United States Abbott Laboratories Full timeAbout Abbott LaboratoriesAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.Job SummaryWe are seeking a highly skilled...
-
Regulatory Compliance Specialist
4 weeks ago
Alameda, California, United States Abbott Laboratories company Full timeAbout Abbott LaboratoriesAbbott Laboratories is a leading global healthcare organization dedicated to enhancing the quality of life for individuals at every stage of their health journey. Our extensive portfolio includes innovative technologies across diagnostics, medical devices, nutritionals, and branded generic medicines, supported by a workforce of...
-
Regulatory Compliance Specialist
4 weeks ago
Alameda, California, United States Abbott Laboratories company Full timeAbout Abbott LaboratoriesAbbott Laboratories is a leading global healthcare organization dedicated to enhancing the quality of life through innovative medical solutions. Our extensive portfolio includes groundbreaking technologies across diagnostics, medical devices, nutrition, and branded generic medicines, supported by a workforce of 114,000 professionals...
-
Regulatory Compliance Specialist
4 weeks ago
Alameda, California, United States Abbott Laboratories company Full timeJoin Abbott LaboratoriesAt Abbott, you have the opportunity to engage in meaningful work, advance your career, and enjoy a fulfilling life while being your authentic self.What We Offer:Career advancement opportunities within a global organization.Comprehensive health coverage for employees through the Health Investment Plan (HIP) PPO.Robust retirement...
-
Lead Specialist in Regulatory Operations
4 weeks ago
Alameda, California, United States Abbott Full timeCompany Overview: Abbott is a leading global healthcare organization dedicated to enhancing the quality of life for individuals at every stage of their health journey. Our extensive range of innovative technologies covers various healthcare sectors, including diagnostics, medical devices, nutritionals, and branded generic medicines. With a workforce of...
-
Senior Regulatory Affairs Specialist
4 weeks ago
Alameda, California, United States Abbott Laboratories company Full timePosition Title: Regulatory Operations Specialist III – Digital Health Technologies Company Overview: Abbott is a leading global healthcare organization dedicated to enhancing the quality of life for individuals at every stage of their health journey. Our extensive portfolio encompasses innovative technologies across various healthcare sectors, including...
-
Regulatory Compliance Specialist III
4 weeks ago
Alameda, California, United States Abbott Laboratories company Full timeAbout AbbottAt Abbott, we offer opportunities that matter, allowing you to grow, learn, and maintain a healthy work-life balance.Benefits You Will Enjoy:Career advancement opportunities within a global organization.Comprehensive medical coverage for employees through the Health Investment Plan (HIP) PPO.Robust retirement savings plan with significant...
-
Senior Scientific Affairs Specialist
2 weeks ago
Alameda, California, United States Abbott Laboratories Full timeAbout the RoleWe are seeking a highly skilled Senior Scientific Affairs Specialist to join our team at Abbott Laboratories. As a key member of our New Medical Sensors group, you will play a critical role in supporting the development and implementation of clinical studies and regulatory submissions.Key ResponsibilitiesStudy Team SupportProvide scientific...