Regulatory Affairs Manager Job
Job Description Job Attributes+
Plano, TX, US
Yes, 5 % of the Time
40 hours per week
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.
For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine ﬁngersticks.
Our Neuromodulation business is an area of expertise for Abbott. This business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. Our Solutions include Proclaim (TM) XR SCS System, the #1 Spinal cord stimulator on the market, Proclaim (TM) DRG Neurostimulator, the only FDA approved DRG therapy and a market leader in radiofrequency ablation therapy, Abbott RFA. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum. Our deep brain stimulation technology for progressive diseases help people manage their Parkinson’s disease and essential tremor symptoms, steering away from side effects.
Our Plano or Austin, Texas locations, currently have an opportunity for a Regulatory Affairs Manager. This position leads project submissions for regulatory approvals and acts independently to identify and resolve problems. This new team member will apply advanced regulatory expertise to guide cross-functional partners and demonstrate strategic thinking and creativity in support of programs.
WHAT YOU’LL DO
- Develops sound global regulatory strategies for new and modified medical devices
- Prepares robust regulatory applications to achieve departmental and organizational objectives
- Creates, reviews and approves engineering changes
- Provides leadership and guidance (including training) to other members of the RA staff as well as to cross-functional team members and development teams
- Reviews device labeling and marketing materials for compliance with FDA submissions and applicable regulations
- Provides global strategic input to development teams (including all feasible alternatives and associated risks)
- Drives cross functional alignment with issues that could have Regulatory ramifications
- Independently interacts and builds partnerships with competent authorities (FDA, and other regulatory agencies)
- Builds strategic partnerships to further departmental and organizational objectives
- Reviews of product and manufacturing changes for compliance with applicable regulations (Change Control)
- Reviews protocols and reports to support regulatory submissions
- Assesses proposed regulations and communicates new requirements to the organization
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
- Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
- Assists with audits and inspections, if required.
- Performs other related duties and responsibilities, on occasion, as assigned
EDUCATION AND EXPERIENCE YOU’LL BRING
- Bachelor’s Degree OR an equivalent combination of education and experience
- 8+ years technical experience
- 6+ years medical device regulatory experience. Extensive experience with US and global medical device regulations and submissions.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
- Ability to work effectively within a team in a fast-paced changing environment.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Multi-tasks, prioritizes and meets deadlines in timely manner.
- Strong organizational, planning, and follow-up skills and ability to hold others accountable.
- Bachelor’s degree in technical discipline
- Experience working in a broader enterprise/cross division business unit model
- Experience with 510(k) applications, IDEs, PMA or PMA supplements and US device regulations and/or experience with EU and other international medical device regulations and submissions
- Experience acting as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team
- Experience acting as liaison between the Company and the various appropriate regulatory agencies, ensuring that communications on both sides are germane, specific and convey all necessary detail
- Experience supporting audits by regulatory agencies, including GMP, ISO13485, and FQA audits
- Experience creating intradepartmental procedures
- Experience leading or supervising a team
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
- Training and career development, with onboarding programs for new employees and tuition assistance
- Financial security through competitive compensation, incentives and retirement plans
- Health care and well-being programs including medical, dental, vision, wellness and occupational health programs. 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.
- Paid time off
- 401(k) retirement savings with a generous company match
- The stability of a company with a record of strong financial performance and history of being actively involved in local communities
Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.
The base pay for this position is $90,700.00 – $181,300.00. In specific locations, the pay range may vary from the range posted.
- Regulatory Requirements
- International Regulations
- REGULATORY SUBMISSIONS
- Regulatory Affairs
- Quality Management Systems
- broader enterprise
- Strategic Thinking
- REGULATORY SUBMISSIONS
- Product Development
Who We Are
PUT YOUR TALENTS TO WORK
Abbott values the leadership skills developed through military service and we have a broad range of functional areas to put your talents to work. Our organization is making a difference in the lives of the people we serve with a diverse offering of healthcare products. We have a strong veteran employee community to help with your transition from the military to the corporate world.