Senior Regulatory Affairs Specialist – Recall and Post-Market Compliance

This is a fully remote position, open to applicants in California, +4 more states.

📋 Description

• Serve as the representative for the Regulatory Affairs department on designated cross-functional project teams.

• Analyze and implement regulations by formulating regulatory strategies for both domestic and international markets.

• Create and execute regulatory plans for intricate projects, which encompass new products and the upkeep of current marketing authorizations.

• Compile hardcopy and electronic information packages for submissions to regulatory agencies.

• Offer guidance on labeling, manufacturing, and analytical and clinical study plans to ensure regulatory compliance.

• Evaluate validation, clinical, and stability protocols and reports for their suitability for regulatory submission.

• Examine manufacturing processes and labeling through change control to assess regulatory reporting implications and compliance.

• Establish, oversee, and collect submission deliverables.

• Draft and revise submission documents utilizing regulatory templates or develop new ones as needed.

• Organize both paper and electronic copies for submission purposes.

• Keep abreast of new and updated regulatory requirements and distribute relevant information.

• Engage with regulatory agencies and third-party accrediting organizations.

• Develop internal procedures aimed at continuous process enhancement.

• Offer regulatory guidance and training to external departments and partners.

• Assist with adverse event reporting, field actions, recalls, post-market surveillance, and regulatory evaluations for currently marketed IVD products.

⛳️ Requirements

• A minimum of 5 years of relevant experience alongside a Bachelor’s degree; or 3 years with a Master’s degree; or a PhD with no prior experience; or equivalent professional experience.

• Preferred: Over 5 years of experience in Regulatory Affairs.

• Experience in an in vitro diagnostics device company is preferred; applicants with backgrounds in pharmaceuticals, biologics, or medical devices are also considered.

• A solid understanding of FDA regulations is required.

• Familiarity with regulatory requirements in the EU, Canada, Australia, Japan, and China is preferred.

• Capability to work autonomously with new, complex technologies and produce high-quality professional outputs.

• Excellent written and verbal communication abilities are essential.

• Leadership skills within a team setting are preferred.

• Proficiency with office automation tools and corporate database applications.

• A strong work ethic and the ability to meet deadlines are crucial.

• Must be authorized to work without visa sponsorship.

🏝️ Benefits

• Variable cash incentive program (bonus or commission).

• Equity options for eligible positions.

• Access to genomic sequencing services.

• Family planning benefits.

• Comprehensive health, dental, and vision insurance.

• Retirement plan benefits.

• Paid time off.

• Employee Resource Groups that provide career development opportunities, cultural awareness initiatives, and social responsibility engagements.