Company : Abbott Laboratories
Country: United States
Location : Plano, Texas
Post: Sun, 05 Nov 2023 09:59:01 GMT
Expires: Sun, 03 Dec 2023 23:59:59 GMT
Apply Job : Apply Online
—————————— Job Description ——————————
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. Our 115,000 colleagues serve people in more than 160 countries.
Working at Abbott
At Abbott, 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) PPO
An excellent retirement savings plan with high employer contribution
Tuition reimbursement, the student debt program and education benefit – an affordable and convenient path to getting a bachelor’s degree.
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum.
We are presently hiring for a Regulatory Affairs Specialist at our location in either Plano or Austin, Texas. This new team member performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Additionally, will support necessary regulatory activities required for product market entry.
The Opportunity
As an individual contributor in the function of a Regulatory Affairs Specialist you will provide support for the Regulatory Affairs department to ensure efficient and compliant business processes and environment. The individual may execute tasks and partner across business functions.
What You’ll Work On
Provide regulatory input to product lifecycle planning.
Partner with cross-functional teams to define scope and assess strategies for maintaining the total product lifecycle – including pre-market development and post-market changes. Apply principles of design control and knowledge of regulations to guide teams to successful regulatory reviews.
Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes for medical devices.
Understand and investigate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval.
Anticipate and navigate regulatory obstacles based on information from international agencies and trends in regulatory environment
Determine and communicate submission and approval requirements. Monitor applications under regulatory review.
Evaluate proposed preclinical, clinical, and manufacturing changes for regulatory filing strategies.
Write, prepare, and review regulatory submissions to authorities.
Maintain annual licenses, registrations, and listings.
Assist compliance with product post-market approval requirements.
Assess external communications relative to regulations. Review regulatory aspects of contracts.
Assist with label development and review for compliance before release.
Individual may provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees. Participates in the development of less experienced staff by setting an example, providing guidance, and offering counsel. Plans and organizes non-routine tasks w/approval. Establishes priorities of work assignments. May lead a departmental project team.
Establishes and cultivates an extensive network of support to facilitate completion of assignments.
Participates in determining goals and objectives for projects.
Influences middle management on technical or business solutions.
Exercises judgment in selecting innovative, practical methods to achieve problem resolution.
Required Qualifications
Bachelor’s degree or an equivalent combination of education and work experience
Minimum of 2 years’ experience in a regulated industry (e.g., medical products, nutritionals, pharma, food). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
Communicate effectively verbally and in writing. Communicate with diverse audiences and personnel. Write and edit technical documents.
Work with cross-functional teams. Work with people from various disciplines and cultures.
Negotiate internally.
Pay strong attention to detail.
Manage projects. Create project plans and timelines.
Think analytically and critically.
Organize and track complex information.
Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
Apply business and regulatory ethical standards.
Preferred Qualifications
Bachelor’s degree in science (such as biology, chemistry, microbiology, neuroscience), math, engineering, or medical fields.
Master’s degree in science or regulatory
1+ year of Regulatory Affairs experience within Medical Devices, including FDA submission (e.g. 510(k), PMA-supplement, IDE) and EU MDR experience
Working knowledge of QSR820, ISO 13485, and Design Controls
Proven outcomes working in matrixed, cross-functional environment
Prefer some knowledge of Regulatory history, guidelines, policies, standards, practices, requirements and precedents; Regulatory agency structure, processes and key personnel; Principles and requirements of applicable product laws; Submission/registration types and requirements; Principles and requirements of promotion, advertising and labeling; Domestic and international regulatory guidelines, policies and regulations; Ethical guidelines of the regulatory profession, clinical research and regulatory process.
Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at , on Facebook at and on Twitter @AbbottNews.Connect with us at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is $56,700.00 – $(phone number removed). In specific locations, the pay range may vary from the range posted.