Job Title: Regulatory Affairs Directors
Employer: Reprieve Cardiovascular, Inc.
Job Location: 459 Fortune Boulevard, Milford, MA 01757
Responsibilities:
The Regulatory Affairs Director will build and lead the global regulatory strategy for our first-in-class heart-failure therapy from clinical development through commercialization. The ideal candidate has deep expertise in FDA and EU medical device regulations and will lead interactions with regulatory authorities to ensure global compliance and product success. Responsibilities include:
- Develop and execute regulatory strategies for U.S. and EU markets, including PMA, IDE, 510k, and CE Mark submissions.
- Manage all aspects of regulatory submissions and discussions including supplements, 5-day notices, Q-sub meetings, notified-body structured dialog interactions, etc.
- Prepare and submit regulatory documentation for breakthrough device designation, original PMA, and EU MDR conformity assessment.
- Serve as the primary liaison with regulatory agencies including the FDA, Notified Bodies, and other international regulators.
- Establish and implement regulatory procedures and SOPs aligned with global requirements and ensure continued compliance with applicable regulations and standards (21 CFR Part 820, ISO 13485, EU MDR, etc.).
- Build and mentor a regulatory team to support submissions, labeling, and compliance activities.
- Oversee the creation, review, and maintenance of regulatory documentation including Design Dossiers, Technical Files, and risk management files.
- Partner with R&D, Quality Assurance, Clinical, Manufacturing, and Marketing to ensure regulatory considerations are incorporated throughout the product lifecycle.
- Co-own, along with Quality, the ISO 13485 quality-management system, risk management (ISO 14971), design-change control and CAPA closure metrics and represent the company regulatory function in audits, inspections, and regulatory meetings.
- Drive global market expansion beyond US/EU, including Canada, Australia, Japan, China and maintenance of MDSAP audit readiness.
Travel: 5% domestic travel required
Telecommuting: Telecommuting is an option.
Requirements & Qualifications:
- Masters's degree in Bioengineering or closely related field
In addition, the employer requires the candidate to have the following:
- At least eight (8) years of work experience in a regulatory affairs role or related occupation within the medical device industry.
- Demonstrated knowledge of global market expansion beyond US/EU gained through eight (8) years of work experience.
- Demonstrated ability to supervise complex regulatory submissions, including early FDA and EU Notified Body engagement, clinical trial support, premarket approvals/clearances, EU MDR conformity assessments, and post-approval changes gained through seven (7) years of work experience.
- Demonstrated ability to lead regulatory teams, develop and execute global regulatory strategies, and ensure compliance for device modifications as well as evolving U.S., EU, and international regulations gained through seven (7) years of work experience.
- Demonstrated ability to build collaborative relationships internally and externally and influence cross-functional stakeholders without direct authority to ensure efficient program execution and secure timely approvals gained through seven (7) years of work experience.
- Demonstrated ability to review and approve device labeling and promotional material to ensure compliance with applicable regulations gained through seven (7) years of work experience.
- Demonstrated ability to drive initiatives to completion, and translate strategy into clear product, development, or operational objective gained through seven (7) years of work experience.
- Demonstrated knowledge of Quality Management Systems (QMS) and Global Regulatory Compliance Including proficiency in ISO 13485, 21 CFR Part 820, EU MDR, and ISO 14971 risk management gained through eight (8) years of work experience.
All years of experience may be gained concurrently.
Alternative Requirements:
- Bachelor's degree in Bioengineering or closely related field.
In addition, the employer requires the candidate to have the following:
- At least ten (10) years of progressively more responsible work experience in a regulatory affairs role or related occupation within the medical device industry.
- Demonstrated knowledge of global market expansion beyond US/EU gained through ten (10) years of work experience.
- Demonstrated ability to supervise complex regulatory submissions, including early FDA and EU Notified Body engagement, clinical trial support, premarket approvals/clearances, EU MDR conformity assessments, and post-approval changes gained through nine (9) years of work experience.
- Demonstrated ability to lead regulatory teams, develop and execute global regulatory strategies, and ensure compliance for device modifications as well as evolving U.S., EU, and international regulations gained through nine (9) years of work experience.
- Demonstrated ability to build collaborative relationships internally and externally and influence cross-functional stakeholders without direct authority to ensure efficient program execution and secure timely approvals gained through nine (9) years of work experience.
- Demonstrated ability to review and approve device labeling and promotional material to ensure compliance with applicable regulations gained through nine (9) years of work experience.
- Demonstrated ability to drive initiatives to completion, and translate strategy into clear product, development, or operational objective gained through nine (9) years of work experience.
- Demonstrated knowledge of Quality Management Systems (QMS) and Global Regulatory Compliance Including proficiency in ISO 13485, 21 CFR Part 820, EU MDR, and ISO 14971 risk management gained through ten (10) years of work experience.
All years of experience may be gained concurrently.
Applicants can send resumes to Reprieve Cardiovascular, Inc at 459 Fortune Boulevard, Milford, MA 01757, apply online at https://reprievecardio.com/careers, or email to careers@reprievecardio.com