Description:

　　DESCRIPTION:

　　The Regulatory Specialist shall be an enthusiastic, hard-working, detail-oriented individual primarily responsible for maintaining Regulatory Compliance. The Regulatory Specialist shall create regulatory policy and procedures to meet the requirements of the countries where client distributes its products.

　　This position will proactively develop collaborative relationships with all functional partners including Marketing, Sales, Operations, Quality and Engineering.

　　RESPONSIBILITIES:

　　• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections. Specifically 510(k), PMA submissions for the FDA and Technical Documentation (Technical File and Design Dossiers) for Europe.

　　• Manages regulatory related projects including implementation of new standards and regulations.

　　• Responsible for Adverse Event (US) and Vigilance Reporting (OUS) regulatory requirements

　　• Responsible for Device Registration where marketed

　　• Responsible for the creating and maintenance of Technical Documentation (EU) for Medical devices for Regulatory purposes.

　　• Manages the compilation of all materials required in submissions, license renewal and annual registrations.

　　• Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.

　　• Coordinates activities with regulatory agencies on defined matters.

　　• Works with R&D to develop strategies for earliest possible approvals of clinical trials applications and regulatory submissions

　　• Keeps abreast of regulatory procedures and changes.

　　Skills:

　　Regulatory affairs, Regulatory, document control, bilingual, FDA, medical device, RAPS

　　Additional Skills & Qualifications:

　　-Bachelors degree in Engineering / Regulatory Affairs

　　-1-3 years experience

　　-Strong Technical writing skills

　　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

　　Actalent is an equal opportunity employer.

　　About Actalent

　　Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.