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Company

Implant Direct · 6 hours ago

Senior Regulatory Affairs Specialist (USA - Remote)

Thousand Oaks, CA

Full-time

Remote

Mid, Senior Level

$83K/yr - $125K/yr

3+ years exp

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Responsibilities

Independently plan, prepare, coordinate, track, follow-up, and obtain clearances for medical device submissions including US 510(k), Health Canada licenses, EU technical files, Brazil, Russia, India, China, Japan, and other countries.

Represent Regulatory Affairs on assigned project teams through all phases of product development, provide Regulatory Strategy and assess regulatory impact of changes on existing products.

Coordinate and prepare document packages for regulatory submissions to the US, EU, and Canada [510(k) Pre-Market Notifications, Product Reports/Supplements, CE Mark, Health Canada].

Responsible in the preparation and compilation of domestic and international product registration submissions. This includes, but is not limited to Pre-Market Notifications, 510ks, CE technical files and international dossiers (such as Canada, China, Brazil, Australia, Japan Russia, India, etc.…).

Represent Regulatory Affairs on change controls and provide regulatory assessment.

Review and approve marketing communication materials.

Provide guidance on global compliance, such as CE Marking and product registrations, clinical evaluations in accordance with MDD Annex II and Annex VII and ISO 13485, Canadian CMDCAS, etc.

Monitor regulatory and legislative environment and provide impact assessment.

Provide information and materials for Certificate to Foreign Governments (CFG), and medical device listings for FDA.

Support external audits (FDA, Notified Body, international regulators, etc.) as requested.

Participate, as assigned, as a CAPA owner, team member, or “task” owner.

Work with project teams and responsible leaders to provide compliance/product registration requirements and potential effects for design changes and manufacturing process changes.

Direct communication with regulatory authorities regarding company’s regulatory filings.

Remain current on developments in field(s) of expertise, regulatory requirements, and industry trends.

Create and update departmental standard operating procedures (SOPs).

Qualification

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Medical device submissions510(k) preparationRegulatory AffairsRegulatory complianceFDA regulationsHealth Canada regulationsISO 13485Technical document writingRegulatory Affairs Certification (RAC)International registrationsDocument management softwareMS-Office Applications

Required

Bachelor's Degree (BA/BS) in Engineering, Life Sciences, or health care-related discipline required.

3 -5 years of experience in Medical devices regulatory submissions required.

Experience with successful preparation and submission of 510(k) and international documents and registration and marketing of medical devices worldwide required.

Preferred

Experience with FDA, Health Canada and international regulators is strongly preferred.

Advanced degree and/or Regulatory Affairs Certification (RAC) preferred.

Ability to clearly communicate and write reports and business correspondence in English.

Ability to effectively present information and respond to questions from groups of managers, clients, customers, and other key members in the company while maintaining a high level of professionalism.

Experience in supporting international registrations.

Knowledge of US and international medical devices regulations, guidelines, and policies.

Expert at compiling medical device documents into clear, easy-to-understand submissions packages.

Expert at writing, reviewing and editing technical documents.

Highly effective at working with cross-functional teams from diverse disciplines and culture.

Must be able to negotiate internally and externally with regulatory agencies.

Identify, communicate and solve regulatory issues with project teams and management.

Strong organizational skills.

Ability to read, understand and retain extensive working knowledge of procedures and company documents.

Excellent MS-Office Applications.

Knowledge of computer files management software (QCBD preferred).

Able to produce positive results with a strong sense of urgency and ability to multi-task.