Regulatory Affairs Manager
Regulatory Affairs Manager
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Salary Not Disclosed
1 Vacancy
Job Description
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Summary
Varex Imaging Corporation is a leading innovator developer and manufacturer of Xray imaging component solutions which includes Xray tubes digital flat panel detectors software and other key components of Xray imaging systems. With a 65 year history of successful innovation you will find our components in countless medical industrial and security imaging applications worldwide. Our mission states that through the talent of our people and vision of customers we help improve and save lives throughout the world by making the invisible visible. Our values of Excellence People Innovation and Customer are foundational to our success in upholding our mission. We cannot make the invisible visible and uphold our mission without our EPIC employees who deliver cutting edge technology globally consistently pursue the highest quality standards engage in a diverse and ethical workforce inspire innovation and showcase a customer mindset. We strive every day to make a difference in the lives of both our customers and theirs.Oversees and directs all product regulatory operations activities. Develops and implements strategies for earliest possible approvals of phase 1 through phase 4 market submissions. Provides counsel to and manages the global regulatory team. Ensures timely preparation of organized and scientifically valid applications in collaboration with engineering teams. Provides expertise in translating regulatory requirements into practical workable plans. Interacts with regulatory agencies around the world. Selects develops and evaluates personnel to ensure the efficient operation of the function.
Job Description
SPECIFIC FUNCTIONS
- Performs all required management responsibilities including but not limited to: implementing the companys policies programs and guidelines; ensuring employee productivity and growth; managing resources; knowing Varexs business; and maintaining functional technical and external market awareness necessary for managing immediate organization.
- Prepare and maintain an annual Regulatory Submission Schedule and corresponding safety file reports.
- Partner with engineering and sales functions to ensure the timely completion of actions related to product introductions or onmarket changes
- Measure monitor and report metrics to ensure system effectiveness and efficiency and implement updates/changes as necessary to meet changing regulatory and business needs.
- Host and interface with various government agencies private companies and consultants (such as US FDA ANVISA BSI EU MDR etc. related to regulatory audits/inspections and assist with the timely response to any findings.
- Develop establish monitor and report on both corporate and departmental quality objectives metrics and goals.
- Promote and ensure companywide quality system compliance with all applicable national and international standards and regulations.
- Perform other duties as assigned.
- Contribute to our culture of being collaborative respectful transparent ethical efficient and highachieving team member
- Establishes the regulatory strategy for each new product introduction approves product and facility changes impacting the regulatory product technical filings project manages the onmarket registrations and provides timely updates to the crossfunctional groups.
Required Skills and Knowledge
- Ability to lead people
- Possess strong analytical skills in Regulatory Intelligence gathering
- Familiarity with MS Office ETQ SAP/ERP and other databases is a plus.
- Proficient in the regulatory submission process within design controls to include product environmental compliance
- Able to read and interpret regulations technical drawings and specifications with support from engineering teams.
- Excellent both written and verbal communication.
Required Certifications and Training
- RAPS certification a plus; Green Belt or Black Belt training a plus
Experience Level with Business Tools
- Proficient in utilizing business tools such as: Email Microsoft Word Excel and PowerPoint.
- Experience with SAP or equivalent ERP product and productivity software desired.
Education and Experience
- Bachelors degree in life sciences or engineering discipline
- 5 years of specific experience in medical device submissions across multiple regulatory agencies 510(k) preferred EU MDR preferred and other international jurisdictions.
- 5 years of management experience for global direct reports
Time Type:
Full timeJob Type:
RegularWork Shift:
N/APay Rate Type:
SalaryBenefits and Perks
Varex Imaging provides competitive pay and benefits to support the financial physical and emotional wellbeing of the people who make our company successful.
Medical Insurance
Dental/Vision
10 Paid Holidays
PTO
Employee Stock Purchase Plan
401K match
Paid Parental Leave
Short & LongTerm Disability and Life Insurance
Competitive Pay
Flexible Schedules
Variety of Shift Options
Free Safety Shoes
Friendly Work Environment
Onsite Cafeteria Company Nurse Credit Union and Gym
Free Coffee and Soda
Tuition Reimbursement
Employee Referral Program
Career Advancement Opportunities
Employee Discounts
EV Charging Stations
All qualified applicants will receive consideration for employment without regard to race sex color religion sexual orientation gender identity national origin protected veteran status or on the basis of disability.
Required Experience:
Manager
Employment Type
Full-Time
