Offer summary

Qualifications:

Bachelor’s degree in a relevant field such as life sciences, engineering, regulatory affairs, or quality management., 10+ years of regulatory affairs experience in the medical device industry, particularly with FDA and Software as a Medical Device (SaMD)., Knowledge of regulatory standards including 21 CFR, ISO 13485, and ISO 27001 is essential., Strong leadership, communication, and negotiation skills are required to manage teams and interact with regulatory authorities..

Key responsibilities:

Lead and mentor a regulatory and quality affairs team, promoting a culture of compliance and continuous improvement.

Develop and implement regulatory strategies to ensure compliance with FDA, MDR, and other global requirements for medical devices.

Coordinate with regulatory authorities to facilitate the approval process and oversee the preparation and submission of regulatory documents.

Collaborate with cross-functional teams to integrate regulatory requirements into product development and monitor regulatory developments.

Job description

RQM+ is the leading MedTech solutions partner, accelerating the product lifecycle from innovation to patient impact. While manufacturers create medical technology, we apply our end-to-end expertise to propel products from concept through market entry and ongoing post-market support.

Our tailored solutions bring unmatched regulatory and quality expertise, FDA-recognized laboratory and materials science, comprehensive clinical trial design and execution, and impactful reimbursement strategies — accelerating market entry and commercial growth. We partner closely with manufacturers across device types and therapeutic areas to deliver life-changing technologies to patients: faster, safer, better.

We don’t make MedTech. We make MedTech happen.

The Director, Regulatory Affairs and Quality Management, will lead the regulatory and quality strategy and operations to ensure compliance with all relevant regulatory requirements, globally, with a specific focus on FDA and Medical Device Regulation (MDR) as applied to Software as a Medical Device (SaMD). The ideal candidate has experience in medical device technology and is capable of navigating the global regulatory landscape to ensure successful product approvals.

Responsibilities:

Lead a high-performing regulatory and quality affairs team (team of five), fostering a culture of compliance and continuous improvement.

Provide strategic direction and mentorship to the regulatory and quality affairs team, ensuring alignment with organizational objectives.

Establish goals for the team and individual team members using knowledge of the industry in alignment with organizational objectives.

Lead Management Review with Executive Team and Board

Lead the preparation, submission, and negotiation of regulatory documents, ensuring timely and successful approvals.

Coordinate with regulatory authorities, including the FDA, European and Australian regulatory bodies to facilitate the approval process.

Develop and implement regulatory strategies to ensure compliance with FDA, MDR, and other global regulatory requirements for medical devices.

Monitor and interpret regulatory developments and trends, advising General Counsel and Leadership Team on potential impacts

Collaborate with cross-functional teams, including R&D, Product, and Marketing to integrate regulatory requirements into product development processes.

Implement robust risk management practices to identify and mitigate regulatory risks.

Ensure alignment with quality management systems (QMS) and regulatory standards, including but not limited to, 21 CFR 820, ISO 13285, and ISO 27001

Oversee regular audits of the departments to ensure compliance with procedures

Provide input into the department Budgeting process

This job description may not be inclusive of all assigned duties and the scope of the job may change as necessitated by business demands.

Requirements:

Bachelor’s degree in a relevant field (e.g., life sciences, engineering, regulatory affairs, quality management)

10+ years of regulatory affairs experience in the medical device industry, with a strong focus on FDA and SaMD

Knowledge of 21 CFR, ISO13485 and ISO 27001

Experience in the IT field, software development, and/or cloud hosting preferred

Training in quality management and quality improvement processes

Strong leadership and team management skills, with the ability to inspire and guide a diverse team

Excellent communication and negotiation skills, with the ability to interact effectively with regulatory authorities and cross-functional teams

Flexible, positive and well-organized team player, comfortable working in a fast-paced software and technology environment

Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today!

We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.

Job Opportunity Verification

At RQM+, we prioritize the security of our job applicants. To ensure a safe application process:

All legitimate RQM+ job opportunities are listed on our official careers page: rqmplus.com/careers

Every candidate going through the interview process will participate in a voice and/or video interview.

Exercise caution with unsolicited job offers or requests for sensitive information.

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