Regulatory Adherence Analyst – Marietta, GA

Optum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data, and resources they need to feel their best. Here, you will find a culture guided by diversity and inclusion, talented peers, comprehensive benefits, and career development opportunities. Come make an impact on the communities we serve as you help us advance health equity on a global scale. Join us to start Caring. Connecting. Growing together.

The Regulatory Analyst will proactively support the execution of the regulatory strategy with a focus on balancing the business needs with regulatory compliance.  The incumbent is responsible for supporting the Optum Distribution Center Quality System (FDA 21 CFR 820) and interactions on regulatory requirements Supports establishment and maintenance of ODC core quality management system processes and procedures in accordance with medical device regulations and standards.

Schedule: Monday – Friday, 8:00AM – 5:00PM

Location: Marietta, GA

Primary Responsibilities:

• Support ODC in ensuring the establishment and maintenance of effective business quality management system processes and procedures in accordance with applicable medical device regulations and standards
• Establish and maintain regulatory and quality management system documents and records
• Lead, coordinate, perform, and/or collaborate in quality management system activities including but not limited to document and record controls, personnel training and competence, CAPA, nonconformity controls, internal audits, supplier quality, investigations, risk and impact assessments, change controls, management reviews, and complaints
• Perform and/or collaborate in medical device regulatory assessments and other related regulatory activities
• Support monitoring, measuring, and reporting of the adequacy and effectiveness of quality management system processes and procedures maintained
• Take necessary actions to correct any identified deficiency, to implement continuous improvements, and to ensure adequacy and effectiveness of the quality management system processes and procedures maintained and implemented
• Ensure the promotion of awareness of applicable regulatory requirements and quality management system requirements across the ODC
• Conduct system administration of software supporting the management of the quality system

What are the reasons to consider working for UnitedHealth Group?   Put it all together – competitive base pay, a full and comprehensive benefit program, performance rewards, and a management team who demonstrates their commitment to your success. Some of our offerings include:

• Paid Time Off which you start to accrue with your first pay period plus 8 Paid Holidays
• Medical Plan options along with participation in a Health Spending Account or a Health Saving account
• Dental, Vision, Life& AD&D Insurance along with Short-term disability and Long-Term Disability coverage
• 401(k) Savings Plan, Employee Stock Purchase Plan
• Education Reimbursement
• Employee Discounts
• Employee Assistance Program
• Employee Referral Bonus Program
• Voluntary Benefits (pet insurance, legal insurance, LTC Insurance, etc.)
• More information can be downloaded at:  http://uhg.hr/uhgbenefits 

You’ll be rewarded and recognized for your performance in an environment that will challenge you and give you clear direction on what it takes to succeed in your role as well as provide development for other roles you may be interested in.

Required Qualifications:

• High School Diploma / GED (or higher)
• 4+ years of experience in the medical device industry, medical device regulatory body, or notifying body

Preferred Qualifications:

• Proficient knowledge of U.S. and International regulatory requirements for medical devices
• Proficient knowledge of the FDA Quality System Regulation (QSR)
• Proficient knowledge of regulations and standards applicable to the medical device industry (such as ISO 13485, ISO 14971, and 21 CFR Part 820)
• Proficient analytical and problem-solving skills, with the ability to identify and address complex issues in a timely manner
• Ability to collaborate effectively

 

The salary range for this role is $59,500 to $116,600 annually based on full-time employment. Pay is based on several factors including but not limited to local labor markets, education, work experience, certifications, etc. UnitedHealth Group complies with all minimum wage laws as applicable. In addition to your salary, UnitedHealth Group offers benefits such as, a comprehensive benefits package, incentive and recognition programs, equity stock purchase and 401k contribution (all benefits are subject to eligibility requirements). No matter where or when you begin a career with UnitedHealth Group, you’ll find a far-reaching choice of benefits and incentives.

  

At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone–of every race, gender, sexuality, age, location, and income–deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups, and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes — an enterprise priority reflected in our mission.

 

 

Diversity creates a healthier atmosphere: UnitedHealth Group is an Equal Employment Opportunity / Affirmative Action employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, protected veteran status, disability status, sexual orientation, gender identity or expression, marital status, genetic information, or any other characteristic protected by law.

 

UnitedHealth Group is a drug – free workplace. Candidates are required to pass a drug test before beginning employment.

 

  

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