FAQs
What are the main responsibilities of a Regulatory Affairs Specialist in this role?
The main responsibilities include researching regulatory issues, providing guidance to cross-functional teams, reviewing labeling and advertising for compliance, identifying regulatory pathways for product designs, executing domestic and international regulatory submissions, tracking application statuses, assessing product changes for regulatory impact, and building strategic partnerships.
What qualifications and experience are required for this position?
The ideal candidate should have a strong background in 510(K) submissions, experience in medical device regulatory affairs, and excellent technical writing skills.
What hard skills should a candidate possess for this role?
Candidates should have expertise in Medical Device Regulatory Affairs, Quality Assurance, GMP Medical Device practices, FDA regulations, and 510(K) submissions.
What soft skills are necessary for a successful Regulatory Affairs Specialist?
Necessary soft skills include efficient project management, technical writing, cross-functional team guidance, strategic partnerships, and effective communication.
Is previous experience with FDA submissions required?
Yes, substantial experience with 510(K) submissions to the FDA is a key requirement for this position.
Does Actalent promote diversity and inclusion within the workplace?
Yes, Actalent promotes diversity, equity, and inclusion as integral parts of its culture, emphasizing hiring diverse talent and maintaining an inclusive environment.
What is the company culture like at Actalent?
Actalent fosters a culture of care, engagement, and recognition with a focus on growth opportunities for its people.
How does Actalent ensure employee growth and development?
Actalent ensures growth opportunities through various initiatives, including persistent self-reflection and building a culture that values engagement and recognition.
Are there accommodations available for applicants with disabilities?
Yes, if you require a reasonable accommodation during the application or interview process due to a disability, you can email actalentaccommodation@actalentservices.com for assistance.
Is this position open to international candidates?
While the job description emphasizes domestic and international regulatory submissions, the specific openness to international candidates may depend on various factors, including work authorization and legal considerations. Therefore, it is advisable to inquire directly for clarification.