Senior Regulatory Affairs Specialist

The Sr. Regulatory Affairs Specialist's 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-

- Collaborate with international counterparts to support global regulatory submissions,

- Minimum 8 years of regulatory affairs experience working in a medical device company

(can be in combination with a regulatory affairs master degree; e.g., Masters in

- 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

- Proactively seeks to develop and become well-versed within the regulatory landscape.

Minimum B.S. or higher in Biomedical Engineering, Electrical Engineering, Mechanical

Engineering, or Pharmacy preferred. Non-technical degrees with equivalent complex medical device experience are acceptable.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.

Required Skills and Experience

• Minimum 8 years of regulatory affairs experience working in a medical device company

(can be in combination with a regulatory affairs master degree; e.g., Masters in

• 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

• Proactively seeks to develop and become well-versed within the regulatory landscape.

Minimum B.S. or higher in Biomedical Engineering, Electrical Engineering, Mechanical

Engineering, or Pharmacy preferred. Non-technical degrees with equivalent complex medical device experience are acceptable.

• RAPS Regulatory Affairs Certification (RAC) is a plus. Primary Function of Position

The Sr. Regulatory Affairs Specialist’s 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-

• Collaborate with international counterparts to support global regulatory submissions,