What are the responsibilities and job description for the Associate Specialist – Premarket Regulatory Affairs position at Applied Medical and Careers?
Applied Medical is a new-generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute to a larger capacity than is possible in typical positions.
Position Description:AREAS OF RESPONSIBILITY
The associate specialist is responsible for contributing to regulatory strategy and submission, participating in projects to maintain and improve the Quality Systems and ensuring that Applied Medical's Quality Systems conforms to standards and regulations in regions where Applied Medical products are distributed. The team member must be capable of working within a team environment, striving to meet customer expectations, and committing to continuous improvements in quality.
REGULATORY AND QUALITY PROJECT MANAGEMENT
Contribute to regulatory submissions, and projects for maintaining and improving the Quality System. Engage in regulatory strategy planning and change management for various markets, including Asia Pacific, Latin America, the European Union, and MENAT (Middle East North Africa). Represent Regulatory Affairs in decision-making and interdepartmental meetings related to domestic and international regulations.
COMMUNICATION
Collaborate with Engineering, Clinical Development, and global regulatory teams to meet regulatory requirements in markets where devices are distributed. Seek guidance and feedback from higher-level authorities, such as the Specialist, Senior Specialist, Manager, Director, or Vice President of Regulatory Affairs, and other teams.
PROBLEM SOLVING
Generate, review, and approve regulatory documentation, including assessments of regulatory actions, declarations of conformity, technical file summaries, and product labeling. Monitor the regulatory environment, keep current on relevant domestic and international standards, regulations, and guidance documents, and implement procedural updates and training to ensure conformance. Consider multiple pathways to compliance and incorporate diverse perspectives when creating solutions.
- At least one year of experience in Regulatory Affairs or Quality Assurance in the medical device industry
- Proficient in interpreting regulations and standards
- Highly motivated, self-starter, able to work independently and as part of a team
- Strong analytical, detail-oriented, proactive mindset, not afraid to ask questions
- Effective oral and written communication and presentation skills
- Friendly, positive attitude, committed to excellent customer service
- Exemplary time and resource management skills, able to multitask, organize, and prioritize
- Strong technical writing skills
- Committed to quality and continuous improvement, strives to meet, or exceed customer expectations
- Bachelor's degree in Engineering, Physical or Biological Sciences, Regulatory, other technical disciplines, or an equivalent field of study
- Training in Quality Systems, including Quality Systems Regulations (QSRs) and Good Manufacturing Practices (GMPs) for medical devices, and International Organization for Standardization (ISO) standards
- Proficiency in speaking and writing in Japanese or Korean is preferred
- Competitive compensation range: $70000 - $80000 / year (California).
- Comprehensive benefits package.
- Training and mentorship opportunities.
- On-campus wellness activities.
- Education reimbursement program.
- 401(k) program with discretionary employer match.
- Generous vacation accrual and paid holiday schedule.
Equal Opportunity Employer
Salary : $70,000 - $80,000