JOB DESCRIPTION:The Opportunity This
Regulatory Affairs Specialist will work out of our Pleasanton, CA location in the Heart Failure Division. As an individual contributor in the function of a Regulatory Affairs Specialist, you will provide support to the Regulatory Affairs department. With limited supervision you will execute tasks and partner across business functions.
As an individual contributor, the Regulatory Affairs Specialist will support product registration and regulatory activities.
What You'll Work On • As a professional in the Regulatory Affairs Sub-Function, possesses developing skills in product registration submission, change order management, progress reports.
• Interacts with regulatory affairs team members and other cross functional team members for regulatory submissions, product licensing and relevant documentation.
• Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
• Serves as regulatory liaison throughout product lifecycle.
• Ensures timely approval of medical devices and continued approval of marketed products.
• May interface with regulatory agencies.
• Conducts reviews of product and manufacturing changes for compliance with applicable regulations.
• Creates, reviews and approves engineering change orders.
• Reviews protocols and reports to support regulatory submissions.
• Supports all business segment initiatives as identified by divisional 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
Required Qualifications - Bachelor's Degree (± 16 years), Technical discipline preferred OR an equivalent combination of education and work experience
- No Experience, some experience with medical device industry preferred.
- Experience working in a broader enterprise/cross-division business unit model preferred. 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 in accomplishing projects. Strong verbal and written communications with the 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.
Preferred Qualifications - Master's Degree (± 18 years), In science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred
- 2 years, In a regulated industry (e.g., medical products, nutritionals). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
- Regulatory 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.
GxPs (GCPs, GLPs, GMPs).
Principles and requirements of promotion, advertising and labeling. Note: This knowledge may be developed through tenure in this position.
Communication Skills or Ability to:
Communicate effectively verbally and in writing.
Learn to write and edit technical documents.
Work with cross-functional teams.
Work with people from various disciplines and cultures.
Cognitive Skills or Ability to:
Pay strong attention to detail.
Handle detailed tasks and prioritize them.
Meet deadlines.
Think analytically and critically.
Review and analyze documentation.
Research and locate information on regulatory requirements and products.
Exercise judgment within defined procedures and practices to determine appropriate action.
Has general knowledge of technical alternatives and gain an understanding of their impact on the systems environment.
Apply business ethical standards.
The base pay for this position is $73,900.00 - $116,000.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Regulatory Operations
DIVISION:HF Heart Failure
LOCATION:United States > Pleasanton : 6101 Stoneridge Dr
ADDITIONAL LOCATIONS:WORK SHIFT:Standard
TRAVEL:No
MEDICAL SURVEILLANCE:No
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
