Senior Regulatory Affairs Specialist
About The Position
The Sr. Regulatory Affairs primary responsibilities include developing regulatory plans, reviewing design input/output documentation, identification of applicable standards and guidance documents, performing regulatory assessments to determine the impact of design/process changes, preparing regulatory submissions, maintaining regulatory filings and licenses. Provide regulatory guidance to product teams, develop regulatory plans, and review and approve product design control documentation. Determine regulatory pathways and formulate regulatory strategies for the U.S. and Canadian markets. Assess regulatory impact on design, materials, labeling, packaging, manufacturing processes, and facility changes. Influence and lead global regulatory strategies. Author and lead regulatory documentation and submissions, including U.S. FDA 510(k) premarket notifications, internal Letters to File, pre-submissions, Health Canada submissions with minimal supervision. Coordinate with technical experts to provide additional data/information requested by regulatory agencies and prepare responses to facilitate regulatory approvals. Provide risk-based guidance and regulatory input to projects and issues, ensuring cross-functional alignment and resolution. Collaborate with international counterparts to support global regulatory submissions, approvals, and implementation rollouts.
Requirements
- Minimum 8 years of regulatory affairs experience working in a medical device company (Can be in combination with a regulatory affairs master's degree; e.g., Masters in Regulatory Science)
- In-depth understanding of US Medical Device regulations, Health Canada guidance and EU MDR.
- Regulatory working knowledge of product lifecycle management, design controls, risk management, verification and validation, and product labeling requirement
- Ability to work in a fast-paced environment and handle multiple projects simultaneously
- Strong verbal and written communication skills, proven ability to translate technical documentation into effective internal documentation, and regulatory submissions
- Team player who seeks to help and learn from colleagues seeing the department success as their own
- Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism
- Proactively seeks to develop and become well-versed within the regulatory landscape.
Nice To Haves
- RAPS Regulatory Affairs Certification (RAC) is a plus.
Responsibilities
- Provide regulatory guidance to product teams, develop regulatory plans, and review and approve product design control documentation.
- Determine regulatory pathways and formulate regulatory strategies for the U.S. and Canadian markets.
- Assess regulatory impact on design, materials, labeling, packaging, manufacturing processes, and facility changes.
- Influence and lead global regulatory strategies.
- Author and lead regulatory documentation and submissions, including U.S. FDA 510(k) premarket notifications, internal Letters to File, pre-submissions, Health Canada submissions with minimal supervision.
- Coordinate with technical experts to provide additional data/information requested by regulatory agencies and prepare responses to facilitate regulatory approvals.
- Provide risk-based guidance and regulatory input to projects and issues, ensuring cross-functional alignment and resolution.
- Collaborate with international counterparts to support global regulatory submissions, approvals, and implementation rollouts.
Benefits
- market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity
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What This Job Offers
Job Type
Full-time
Career Level
Senior
