Regulatory Afairs Specialist
2 weeks ago
**Exciting opportunity with Medical Device company specializing in Women's Health**
Description:
+ As a regulatory specialist, you will develop and implement medical device regulatory strategies to obtain timely approvals from worldwide regulatory bodies. From developing and authoring regulatory submissions to providing critical input on cross-functional project teams you will ensure submissions are accurately prepared and comply with global regulations. The position is on-site at our Westlake Village location and may require additional hours and/or travel as necessary to complete time-sensitive projects.
+ Work with a cross-functional team to provide regulatory support for new product introduction and existing products. Work with quality, engineers, and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
+ Provide regulatory input and guidance to cross-functional partners, developing global regulatory strategies for all devices and preparing and submitting regulatory submissions in the both the US and OUS geographies.
+ Prepare Technical Files /Design Dossier, Change Notifications, Submissions (e.g. Documentary Audits under MDD/ MDR) for both regulatory agencies and distributors.
+ Creates, reviews and approves change requests.
+ Assist with defining the regulatory strategy and manage regulatory submission activities for complex product development activities and product maintenance for existing approved products.
+ Interprets new or existing regulatory requirements as they relate to the product portfolio and regulatory and quality system procedures.
+ Support or prepare regulatory submissions for new products and product changes, as required, to ensure timely approvals for market release. Review significant product submissions with manager and negotiate submission issues with agency personnel.
+ Reviews protocols and reports to support regulatory submissions.
+ Maintain proficiency in global quality and regulatory requirements.
+ Demonstrate strong project management, writing, coordination, and execution of regulatory items, with emphasis on technical and scientific regulatory activities.
+ Provide regulatory input to product lifecycle planning.
+ Provide feedback and on-going support to product development teams for regulatory issues and questions.
+ Provide support for clinical studies, such as preparing and/or submitting regulatory documents, interaction between sites, support site requests, technical documentation, maintenance of all study files.
+ Responsibilities may include the following and other duties may be assigned.
Desired Skills:
Regulatory affairs, iso 13485, bachelors, technical documentation, EU mdr, MDR, global submissions, change notifications, 21 cfr 820, ISO 14971, Regulatory compliance, Medical device, Regulatory submission, Regulatory documents, Quality assurance, 510k submissions, product registrations
Additional Skills & Qualifications:
+ B.S. degree in a biomedical, biotechnology, regulatory sciences, certifications with RAPS, ASQ, CQE preferred.
+ 3-5 years experience in International Regulatory Affairs preferably in the Medical Device industry.
Experience Level:
Intermediate Level
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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.
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