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Sr Regulatory Affairs Specialist - Carlsbad, United States - Actalent
Description
*Must have EU regulatory experience with MDD and MDR.
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.
Responsibilities:
● 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.
Skills:
MDR, Regulatory affairs, Medical device, Dental, European Medical Device, submissions, Regulatory documents
Additional Skills & Qualifications:
• Senior Regulatory Affairs professional with a minimum of 8-10 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.
• Demonstrated interest and capability in learning subject matter and processes.
• Demonstrated ability to solve problems with limited supervision.
• Demonstrated effective interpersonal, teamwork, and communication skills required.
• 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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