- Help with the movement from old med device reg to the new regs (MDD to MDR)
- Design system and documentation
- Must know regulations well, what strategies work to get submittions,
- Some clinical experience/knowledge – report out this data
- No human trials, but they still do studies wirhthe products (whyt he clinial experience – undrtand safety and performance, read studies)
- Quality experience is a plus
- Good writing, communication, can work alone and in a team
- Don't need dental experience
- 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
Sr Regulatory Affairs Specialist - Carlsbad, United States - Actalent
Description
Description:
The Sr. Regulatory Affairs Specialist - Europe participates and manages necessary regulatory and project management activities required for medical device registration and compliance, with a focus on European Medical Device registration. The candidate must have successfully demonstrated technical
proficiency, creativity, initiative, independent thinking, and collaboration with others. Plan and prepare global regulatory dossiers with a focus on Medical Device Technical Files in accordance with MDD and MDR. Assist the Regulatory Affairs Director with Regulatory activities to ensure compliance with the new European Medical Device Regulations (MDR). Ensure compliance with US and international regulations and guidelines. Provides routine regulatory support, which may include, but not limited to: Support the compilation, development, submission, and maintenance of worldwide regulatory filings; Track regulatory project status and informational documents; Create timelines and track deliverables to timelines to ensure that all submissions are submitted on time; Interface with global Regulatory partners and internal cross-functional teams; and, Attend relevant functional area and project team meetings as required.
Additional Skills & Qualifications:
5-10 years of experience authoring medical device Technical Files, in accordance with MDD, successfully approved by European
Notified Body for CE marking. Must be able to work independently with minimum direction
from supervisor. Must have experience in label review/approval for CE marking. Must be
knowledgeable in MDR requirements. Experience in the dental field is a plus.
Bachelor's Degree in biology, chemistry, biochemistry, microbiology, or related discipline.
Experience with the use of spreadsheets, word processing, and database application software
(i.e. Excel, Adobe, Word).
Flexibility and agility to accommodate project changes and time constraints. Ability to work in collaborative and independent work situations with minimal supervision. Ability to use Regulatory information systems.
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:
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.
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