Regulatory Affairs Specialist
3 weeks ago
Job Title: Regulatory Operations
Location: Santa Clara, CA 95054
Duration: 6 Months
Description / Summary:
This role will provide compliance support to the Regulatory Affairs organization by
a. Driving preparation of KPI dashboards and maintaining a pulse on formal RA management review and internal metrics.
b. Managing strategic program for RA audit preparedness including anticipatory identification of risks, mitigation of risks identified during the audit process, and preventive actions for risks.
c. Supporting quality system integration for acquisitions and new product introductions.
d. Identifying and implementing system and/or systemic processes.
e. Supporting tracking and maintenance of regulatory post-approval commitments.
f. Driving quality system process improvement initiatives
Initiatives include but are not limited to:
1. Establishing audit support for integration products,
2. Improving and Maintaining the quality system procedures (e.g., change management)
3. Liaising with cross-functional partners and international affiliates to meet audit compliance needs and driving to implementation/resolution.
4. Participating in audit backrooms, and
5. Participating in RA projects.
Role has a potential for investigating nonconformances (CAPAs) and implementing mitigations. Exposure to Medical Device US and CE regulations, Quality Systems, a Quality role, or a Compliance role is a plus.
List of tasks:
RA Change Requests Tracking and Closure
Change management
Develop and implement an auditing plan for critical RA tasks (e.g., mock audits for Technical Files/Technical Documentations, Impact Assessments, Archival) as part of audit risk mitigation activities.
CAPAs/Auding Finding management.
Post-Approval Commitments management
Support QMS audits from an RA perspective
Support QMS Integration tasks
Management Review Metrics results
Skills:
Independent
Troubleshooting
Critical thinker
Ability to drive a problem through resolution and implement mitigations.
Ability to handle multiple streams simultaneously.
-
Regulatory Affairs Specialist
2 weeks ago
Santa Clara, United States GForce Life Sciences Full timeRegulatory Affairs Specialist– Santa Clara, CA Must be able to work on a W2 Job Summary: We are seeking a regulatory affairs specialist to assist and lead in the definition/implementation of regulatory strategy and priorities in conjunction with management, peers, and commercial, and affiliate personnel in the medical device industry.Key...
-
Regulatory Affairs Specialist
2 weeks ago
Santa Clara, United States GForce Life Sciences Full timeRegulatory Affairs Specialist Santa Clara, CA Must be able to work on a W2 Job Summary: We are seeking a regulatory affairs specialist to assist and lead in the definition/implementation of regulatory strategy and priorities in conjunction with management, peers, and commercial, and affiliate personnel in the medical device industry. Key...
-
Regulatory Affairs Specialist
4 weeks ago
Santa Clara, United States GForce Life Sciences Full timeRegulatory Affairs Specialist– Santa Clara, CA Must be able to work on a W2 Job Summary: We are seeking a regulatory affairs specialist to assist and lead in the definition/implementation of regulatory strategy and priorities in conjunction with management, peers, and commercial, and affiliate personnel in the medical device industry.Key...
-
Regulatory Affairs Specialist
1 month ago
Santa Clara, United States GForce Life Sciences Full timeRegulatory Affairs Specialist– Santa Clara, CA Must be able to work on a W2 Job Summary: We are seeking a regulatory affairs specialist to assist and lead in the definition/implementation of regulatory strategy and priorities in conjunction with management, peers, and commercial, and affiliate personnel in the medical device industry.Key...
-
Regulatory Affairs Specialist
1 month ago
Santa Clara, United States GForce Life Sciences Full timeRegulatory Affairs Specialist II – Santa Clara, CA Must be able to work on a W2Job Summary We're looking for a Regulatory Specialist with 2-5 years of experience in the medical device industry. Your responsibilities include maintaining the quality system, supporting manufacturing operations, and providing regulatory guidance. Experience with international...
-
Regulatory Affairs Specialist
1 month ago
Santa Clara, United States GForce Life Sciences Full timeRegulatory Affairs Specialist II – Santa Clara, CA Must be able to work on a W2Job Summary We're looking for a Regulatory Specialist with 2-5 years of experience in the medical device industry. Your responsibilities include maintaining the quality system, supporting manufacturing operations, and providing regulatory guidance. Experience with international...
-
Regulatory Affairs Specialist
10 hours ago
Santa Clara, United States GForce Life Sciences Full timeRegulatory Affairs Project Lead– Santa Clara, CA Must be able to work on a W2 Job Summary: We are seeking a regulatory affairs specialist to assist and lead in the definition/implementation of regulatory strategy and priorities in conjunction with management, peers, and commercial, and affiliate personnel in the medical device industry. Key...
-
Regulatory Specialist
1 week ago
Santa Clara, United States INTELLECTT INC Full timeHi One of our medical clients is looking for the role Regulatory Specialist , if you are interested or your skills matches please share with me your updated resume tanmai@intellectt.com Role: Regulatory Specialist Location: Santa Clara, CA Duration: 12 Months Job Description Support regulatory department for efficient and compliant processes. Execute tasks...
-
Regulatory Affair
5 days ago
Santa Clara, United States Select Source International Full timeJob DescriptionJob DescriptionTitle: - Regulatory Affairs Project LeaderDuration: - 12+ Month Education: Bachelor's degree required, Master’s degree preferred Experience: Minimum of 3 years of Regulatory Affairs experience Skills: Knowledge of US and/or Canadian regulations or with EU and other international medical device regulations relating to...
-
Regulatory Affairs Associate
4 weeks ago
Santa Clara, United States GForce Life Sciences Full timeRegulatory Affairs Associate – Santa Clara, CA MUST BE ABLE TO WORK ON A W2Job Summary:The Regulatory Affairs Compliance Support role is pivotal in ensuring adherence to regulatory standards by providing crucial support to the Regulatory Affairs (RA) organization. The position involves driving key performance indicator (KPI) dashboards, managing strategic...
-
Regulatory Affairs Associate
3 weeks ago
Santa Clara, United States GForce Life Sciences Full timeRegulatory Affairs Associate – Santa Clara, CA MUST BE ABLE TO WORK ON A W2Job Summary:The Regulatory Affairs Compliance Support role is pivotal in ensuring adherence to regulatory standards by providing crucial support to the Regulatory Affairs (RA) organization. The position involves driving key performance indicator (KPI) dashboards, managing strategic...
-
Regulatory Affairs Associate
4 weeks ago
Santa Clara, United States GForce Life Sciences Full timeRegulatory Affairs Associate – Santa Clara, CA MUST BE ABLE TO WORK ON A W2Job Summary:The Regulatory Affairs Compliance Support role is pivotal in ensuring adherence to regulatory standards by providing crucial support to the Regulatory Affairs (RA) organization. The position involves driving key performance indicator (KPI) dashboards, managing strategic...
-
Regulatory Affairs Project Leader
2 days ago
Santa Clara, United States Collabera Full timeJob DescriptionJob Description· Education: Bachelor's degree required, Master’s degree preferred· Experience: Minimum of 3 years of Regulatory Affairs experience· Skills: Knowledge of US and/or Canadian regulations or with EU and other international medical device regulations relating to product and/or...
-
Regulatory Affairs Project Leader
2 hours ago
Santa Clara, United States Collabera Full timeJob Description Job Description · Education: Bachelor's degree required, Master’s degree preferred · Experience: Minimum of 3 years of Regulatory Affairs experience · Skills: Knowledge of US and/or Canadian regulations or with EU and other international medical device regulations relating to product and/or device submissions. · Hands-on experience with...
-
Regulatory Affairs Project Leader
11 hours ago
Santa Clara, United States Planet Pharma Full time1-Year Contract $50-$52/hour Duties:Assists in definition/implementation of regulatory strategy and priorities in conjunction with management, peers, commercial, and affiliate personnel.Communicates issues to management through project management tracking and issue briefings.Position is highly visible to internal and external stakeholders.High level of...
-
Regulatory Affairs Project Leader
2 days ago
Santa Clara, United States Planet Pharma Full time1-Year Contract $50-$52/hour Duties:Assists in definition/implementation of regulatory strategy and priorities in conjunction with management, peers, commercial, and affiliate personnel.Communicates issues to management through project management tracking and issue briefings.Position is highly visible to internal and external stakeholders.High level of...
-
Regulatory Affairs Associate
1 month ago
Santa Clara, United States CareerBuilder Full timeThe Fountain Group is a national staffing firm and we are currently seeking a Regulatory Affairs Associate for a prominent client of ours. This position is located in Santa Clara, CA Details for the position are as follows: Job Description: Details: Pay for this position is 40.00 to 45.00 hourly depending on experience. This position is a contract with the...
-
Regulatory Affairs Associate
2 weeks ago
Santa Clara, United States The Fountain Group Full timeThe Fountain Group is a national staffing firm and we are currently seeking a Regulatory Affairs Associate for a prominent client of ours. This position is located in Santa Clara, CA Details for the position are as follows: Job Description: Details: Pay for this position is 40.00 to 45.00 hourly depending on experience. This position is a contract with the...
-
Regulatory Affairs Manager
4 weeks ago
Santa Ana, United States McGuff Family of Companies Full time**The McGuff Company Inc. is growing and looking to hire a Regulatory Affairs Manager** McGuff values its employees as one of its most important resources. We strive for a vibrant, healthy work culture and attain it through good communication, active involvement, and corporate responsibility. We leverage our employees’ expertise and support their...
-
Regulatory Affairs Manager
1 day ago
Santa Fe, United States Essity Full timeRegulatory Affairs Manager page is loaded Regulatory Affairs Manager Apply remote type Hybrid locations Santa Fe (Ciudad de México) , Mexico time type Full time posted on Posted 2 Days Ago job requisition id Essity243493 Regulatory Affairs Manager In Tork we want to shape the PH market, so we are looking for someone to provide market-relevant regulatory...