Implant Direct Regulatory Affairs Specialist (Thousand Oaks, CA)

Regulatory Affairs Specialist

The Regulatory Affairs Specialist is responsible for planning, preparing, coordinating, and managing global regulatory submissions and registrations for medical devices, including US 510(k), EU technical documentation, and international dossiers. The role represents Regulatory Affairs on cross-functional project teams, provides regulatory strategy, assesses the impact of design and manufacturing changes, and ensures compliance across global markets. Key activities include compiling submission packages, interacting with regulatory authorities, supporting audits, reviewing marketing materials, monitoring regulatory developments, and maintaining SOPs to ensure ongoing compliance and effective regulatory operations.

Primary Duties & 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).

Job Requirements:

• Bachelor's Degree (BA/BS) in Engineering, Life Sciences, or health care-related discipline required.
• 3 years of experience in Medical devices regulatory submissions required.
• 3 years' experience with successful preparation and submission of 510(k) and international documents and registration and marketing of medical devices worldwide required.

Preferred Qualifications:

• 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.
• Strong interpersonal and presentation skills.
• Knowledge of Quality System Requirements and Standards.

Target Market Salary Range:

$85,800 - $104,800

Operating Company:

Implant Direct