Jobot
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Base pay range
$95,000.00/yr - $135,000.00/yr Want to learn more about this role and Jobot? Click our Jobot logo and follow our LinkedIn page!
Job details
Reputable Medical Device Company - Looking for Regulatory Affairs Manager
This Jobot Job is hosted by Victoria Casal
Are you a fit? Easy Apply now by clicking the "Easy Apply" button and sending us your resume.
Salary $95,000 - $135,000 per year
A Bit About Us
** THIS IS AN ONSITE POSITION IN VALENCIA **
Reputable Medical Device company
Why join us?
Competitive Salary
Benefits (Medical/ Dental/ Vision)
PTO Package
401K
Bonus
Flexible work environment
Job Details
** THIS IS AN ONSITE POSITION IN VALENCIA **
Job Details
We are currently seeking a highly motivated, detail-oriented, and experienced Regulatory Affairs Manager to join our dynamic team in the medical device industry. This role requires a strategic thinker with a strong understanding of the regulatory landscape, who can lead and manage regulatory activities while ensuring compliance with local, national, and international regulatory standards. The Regulatory Affairs Manager will have the confidence and competence to make critical regulatory decisions and will be responsible for overseeing all aspects of regulatory affairs, including quality assurance, quality control, and compliance with ISO 13485, CA-RHB, cGMP, and CMDR. The successful candidate must have a minimum of 5+ years of experience in a similar role.
Responsibilities
Manage and oversee all regulatory affairs activities to ensure compliance with local, national, and international regulations and standards. Develop and implement regulatory strategies and processes to support the company's business objectives. Coordinate and prepare regulatory submissions for new products and product changes as required to ensure timely approvals. Maintain the company's quality system in compliance with ISO 13485, CA-RHB, cGMP, and CMDR. Oversee quality control and quality assurance activities, ensuring the highest standards are met. Manage CAPAs, CAPARs, SS&DRs processes to identify and address non-conformities and drive continuous improvement. Liaise with regulatory authorities and represent the company at regulatory meetings and inspections. Monitor changes in regulatory legislation and guidelines and implement necessary changes to maintain compliance. Provide regulatory guidance and training to cross-functional teams within the organization.
Qualifications
A minimum of 5+ years of experience in regulatory affairs in the scientific industry. Bachelor's degree in a scientific discipline, or equivalent. Advanced degree preferred. Proven experience in managing and implementing ISO 13485, CA-RHB, cGMP, and CMDR. Strong knowledge of quality control, quality assurance, CAPAs, CAPARs, and SS&DRs. Excellent strategic thinking, problem-solving, and decision-making skills. Ability to manage multiple projects and meet deadlines. Strong written and verbal communication skills. Ability to work cross-functionally and build relationships with internal and external stakeholders. Demonstrated leadership skills and the ability to influence at all levels of the organization. Strong understanding of the regulatory landscape and ability to interpret and apply regulatory guidelines.
Interested in hearing more? Easy Apply now by clicking the "Easy Apply" button.
Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.
Want to learn more about this role and Jobot?
Click our Jobot logo and follow our LinkedIn page!
Seniority level
Seniority level Not Applicable Employment type
Employment type Full-time Job function
Job function Legal Industries Biotechnology Research, Research Services, and Nanotechnology Research Referrals increase your chances of interviewing at Jobot by 2x Sign in to set job alerts for “Regulatory Affairs Manager” roles.
Santa Clarita, CA $100,000.00-$160,000.00 1 week ago Los Angeles, CA $73,900.00-$110,000.00 2 weeks ago Santa Clarita, CA $100,000.00-$140,000.00 17 hours ago Santa Clarita, CA $140,000.00-$170,000.00 5 days ago Burbank, CA $95,000.00-$135,000.00 3 days ago Santa Clarita, CA $100,000.00-$140,000.00 1 month ago Burbank, CA $97,200.00-$145,800.00 3 days ago Santa Clarita, CA $38.46-$48.08 1 month ago Equity and Compliance Manager for Academic Recruitment
Northridge, CA $100,000.00-$115,000.00 1 month ago Santa Clarita, CA $90,000.00-$110,000.00 1 week ago Agoura Hills, CA $60,000.00-$80,000.00 1 month ago Quality Control Regulatory Compliance Senior Analyst
Moorpark, CA $65,000.00-$100,000.00 5 days ago Los Angeles, CA $75,000.00-$85,000.00 1 month ago Corporate Paralegal / Executive Assistant
Universal City, CA $90,000.00-$120,000.00 2 months ago Simi Valley, CA $62,741.00-$88,935.00 2 days ago Business Analyst (GRC - Governance Risk Compliance)
Universal City, CA $110,000.00-$110,000.00 2 days ago Director of Performance Improvement and Risk Manager
Santa Clarita, CA $130,000.00-$150,000.00 4 days ago San Fernando, CA $125,000.00-$135,000.00 1 month ago Beverly Hills, CA $90,000.00-$110,000.00 1 week ago Universal City, CA $90,000.00-$120,000.00 2 months ago Burbank, CA $85,000.00-$110,000.00 3 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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$95,000.00/yr - $135,000.00/yr Want to learn more about this role and Jobot? Click our Jobot logo and follow our LinkedIn page!
Job details
Reputable Medical Device Company - Looking for Regulatory Affairs Manager
This Jobot Job is hosted by Victoria Casal
Are you a fit? Easy Apply now by clicking the "Easy Apply" button and sending us your resume.
Salary $95,000 - $135,000 per year
A Bit About Us
** THIS IS AN ONSITE POSITION IN VALENCIA **
Reputable Medical Device company
Why join us?
Competitive Salary
Benefits (Medical/ Dental/ Vision)
PTO Package
401K
Bonus
Flexible work environment
Job Details
** THIS IS AN ONSITE POSITION IN VALENCIA **
Job Details
We are currently seeking a highly motivated, detail-oriented, and experienced Regulatory Affairs Manager to join our dynamic team in the medical device industry. This role requires a strategic thinker with a strong understanding of the regulatory landscape, who can lead and manage regulatory activities while ensuring compliance with local, national, and international regulatory standards. The Regulatory Affairs Manager will have the confidence and competence to make critical regulatory decisions and will be responsible for overseeing all aspects of regulatory affairs, including quality assurance, quality control, and compliance with ISO 13485, CA-RHB, cGMP, and CMDR. The successful candidate must have a minimum of 5+ years of experience in a similar role.
Responsibilities
Manage and oversee all regulatory affairs activities to ensure compliance with local, national, and international regulations and standards. Develop and implement regulatory strategies and processes to support the company's business objectives. Coordinate and prepare regulatory submissions for new products and product changes as required to ensure timely approvals. Maintain the company's quality system in compliance with ISO 13485, CA-RHB, cGMP, and CMDR. Oversee quality control and quality assurance activities, ensuring the highest standards are met. Manage CAPAs, CAPARs, SS&DRs processes to identify and address non-conformities and drive continuous improvement. Liaise with regulatory authorities and represent the company at regulatory meetings and inspections. Monitor changes in regulatory legislation and guidelines and implement necessary changes to maintain compliance. Provide regulatory guidance and training to cross-functional teams within the organization.
Qualifications
A minimum of 5+ years of experience in regulatory affairs in the scientific industry. Bachelor's degree in a scientific discipline, or equivalent. Advanced degree preferred. Proven experience in managing and implementing ISO 13485, CA-RHB, cGMP, and CMDR. Strong knowledge of quality control, quality assurance, CAPAs, CAPARs, and SS&DRs. Excellent strategic thinking, problem-solving, and decision-making skills. Ability to manage multiple projects and meet deadlines. Strong written and verbal communication skills. Ability to work cross-functionally and build relationships with internal and external stakeholders. Demonstrated leadership skills and the ability to influence at all levels of the organization. Strong understanding of the regulatory landscape and ability to interpret and apply regulatory guidelines.
Interested in hearing more? Easy Apply now by clicking the "Easy Apply" button.
Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.
Want to learn more about this role and Jobot?
Click our Jobot logo and follow our LinkedIn page!
Seniority level
Seniority level Not Applicable Employment type
Employment type Full-time Job function
Job function Legal Industries Biotechnology Research, Research Services, and Nanotechnology Research Referrals increase your chances of interviewing at Jobot by 2x Sign in to set job alerts for “Regulatory Affairs Manager” roles.
Santa Clarita, CA $100,000.00-$160,000.00 1 week ago Los Angeles, CA $73,900.00-$110,000.00 2 weeks ago Santa Clarita, CA $100,000.00-$140,000.00 17 hours ago Santa Clarita, CA $140,000.00-$170,000.00 5 days ago Burbank, CA $95,000.00-$135,000.00 3 days ago Santa Clarita, CA $100,000.00-$140,000.00 1 month ago Burbank, CA $97,200.00-$145,800.00 3 days ago Santa Clarita, CA $38.46-$48.08 1 month ago Equity and Compliance Manager for Academic Recruitment
Northridge, CA $100,000.00-$115,000.00 1 month ago Santa Clarita, CA $90,000.00-$110,000.00 1 week ago Agoura Hills, CA $60,000.00-$80,000.00 1 month ago Quality Control Regulatory Compliance Senior Analyst
Moorpark, CA $65,000.00-$100,000.00 5 days ago Los Angeles, CA $75,000.00-$85,000.00 1 month ago Corporate Paralegal / Executive Assistant
Universal City, CA $90,000.00-$120,000.00 2 months ago Simi Valley, CA $62,741.00-$88,935.00 2 days ago Business Analyst (GRC - Governance Risk Compliance)
Universal City, CA $110,000.00-$110,000.00 2 days ago Director of Performance Improvement and Risk Manager
Santa Clarita, CA $130,000.00-$150,000.00 4 days ago San Fernando, CA $125,000.00-$135,000.00 1 month ago Beverly Hills, CA $90,000.00-$110,000.00 1 week ago Universal City, CA $90,000.00-$120,000.00 2 months ago Burbank, CA $85,000.00-$110,000.00 3 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr