Job Description

3 days ago Be among the first 25 applicants

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Base pay range

$95,000.00/yr - $135,000.00/yr

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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.

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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

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Job Tags

Full time, Local area, Flexible hours,

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