What are the responsibilities and job description for the Medical Device Regulatory Affairs position at Actalent?
Key Responsibilities:
- Develop and implement regulatory strategies for new and existing medical devices.
- Prepare and submit regulatory documentation to FDA, CE Mark, and other international regulatory bodies.
- Ensure compliance with ISO 13485, MDR, IVDR, and other relevant standards.
- Manage regulatory submissions, including 510(k), PMA, and clinical trial applications.
- Monitor and interpret regulatory changes and communicate their impact to the team.
- Collaborate with cross-functional teams to ensure regulatory requirements are met throughout the product lifecycle.
- Provide regulatory guidance during product development and post-market activities.
- Maintain regulatory files and documentation in accordance with company policies and procedures.
Qualifications:
- Bachelor's degree in a related field (e.g., Life Sciences, Engineering, Regulatory Affairs).
- Minimum [X] years of experience in regulatory affairs within the medical device industry.
- In-depth knowledge of FDA regulations, ISO 13485, CE Mark, MDR, IVDR, and other relevant standards.
- Proven experience with regulatory submissions (510(k), PMA, clinical trials).
- Strong analytical and problem-solving skills.
- Excellent written and verbal communication skills.
- Ability to work independently and as part of a team.
- Detail-oriented with strong organizational skills.
Benefits:
- Competitive salary and benefits package.
- Opportunities for professional growth and development.
- Collaborative and innovative work environment.
Pay and Benefits
The pay range for this position is $24.00 - $30.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Newbury Park,CA.
Application Deadline
This position is anticipated to close on Mar 24, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Salary : $24 - $30
