Regulatory Affairs Specialist
- $37.5 - $48
- Santa Clarita, CA
Reputable Medical Device Company - Looking for Full Time Regulatory Affairs Specialist
A bit about us:
** THIS IS AN ONSITE POSITION IN VALENCIA (Occasionally in Burbank) **
Reputable Medical Device company
Reputable Medical Device company
Why join us?
Competitive Salary
Employer paid Benefits (Medical/ Dental/ Vision)
PTO Package
Health Care and Dependent Care Flex Spending
401K
Profit-sharing program
Flexible work environment
Employer paid Benefits (Medical/ Dental/ Vision)
PTO Package
Health Care and Dependent Care Flex Spending
401K
Profit-sharing program
Flexible work environment
Job Details
Responsibilities:
1. Develop and implement regulatory strategies and plans to ensure timely and successful market introduction of new products and updates to existing products.
2. Prepare and maintain technical files and design dossiers to support CE marking of products, including risk analysis and post-market surveillance reports.
3. Review and approve product labeling, promotional materials, and product changes as per regulatory requirements.
4. Ensure compliance with ISO 9001 and ISO 13485, MDR, EU MDD, MDD, CFR, and other relevant standards.
5. Maintain a robust document management system and ensure its compliance with regulatory requirements.
6. Liaise with regulatory authorities and notified bodies to resolve any issues that may arise during the product approval process.
7. Actively participate in internal and external audits and inspections.
8. Continuously monitor changes in the regulatory landscape and update the internal teams accordingly.
Qualifications:
1. A minimum of a Bachelor's degree in a scientific or technical field, or equivalent.
2. Minimum 4+ years of experience in regulatory affairs in the scientific industry.
3. Strong knowledge of QA, Quality Assurance, Quality Controls, ISO 9001, ISO13485, MDR, EU MDD, MDD, CFR, and Document Management.
4. Excellent written and verbal communication skills.
5. Strong analytical and problem-solving skills.
6. Ability to work collaboratively with cross-functional teams.
7. Strong attention to detail and the ability to manage multiple tasks simultaneously.
8. Proven track record of successful product approvals and audits.
9. Proficiency in using document management systems and other software tools.
You must be able to travel and work in Valencia with occasional visits to the Burbank facility.
1. Develop and implement regulatory strategies and plans to ensure timely and successful market introduction of new products and updates to existing products.
2. Prepare and maintain technical files and design dossiers to support CE marking of products, including risk analysis and post-market surveillance reports.
3. Review and approve product labeling, promotional materials, and product changes as per regulatory requirements.
4. Ensure compliance with ISO 9001 and ISO 13485, MDR, EU MDD, MDD, CFR, and other relevant standards.
5. Maintain a robust document management system and ensure its compliance with regulatory requirements.
6. Liaise with regulatory authorities and notified bodies to resolve any issues that may arise during the product approval process.
7. Actively participate in internal and external audits and inspections.
8. Continuously monitor changes in the regulatory landscape and update the internal teams accordingly.
Qualifications:
1. A minimum of a Bachelor's degree in a scientific or technical field, or equivalent.
2. Minimum 4+ years of experience in regulatory affairs in the scientific industry.
3. Strong knowledge of QA, Quality Assurance, Quality Controls, ISO 9001, ISO13485, MDR, EU MDD, MDD, CFR, and Document Management.
4. Excellent written and verbal communication skills.
5. Strong analytical and problem-solving skills.
6. Ability to work collaboratively with cross-functional teams.
7. Strong attention to detail and the ability to manage multiple tasks simultaneously.
8. Proven track record of successful product approvals and audits.
9. Proficiency in using document management systems and other software tools.
You must be able to travel and work in Valencia with occasional visits to the Burbank facility.
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.
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.