Director, Regulatory Affairs

Job Description

Job Description

Overview / Job Summary :

We are looking for smart, curious, and passionate individuals to join our culturally diverse team and contribute to our shared success.

In this position you will provide regulatory leadership to the Biomeme Leadership Team and contribute to the development of Biomeme’s platform strategy and operational plans through sound assessments of regulatory pathways and risks. Such assessments may influence the scientific or technical direction of product design and / or development. Ideal candidates will partner with Marketing, Business Development, and other functional leaders to create unique market entry and sustainability strategies while maintaining strict regulatory compliance. In addition, you will play an important role in developing the regulatory infrastructure at a rapidly growing company. Ideal candidates will have a proven record of approving medical devices for sale in the USA, Canada and the EU. Candidates should have demonstrated ability to lead an organization to appropriate decision-making.

Responsibilities / Essential Functions :

• Assess regulatory pathways for new products and product modifications; develops regulatory strategies and tactical plans for submissions to FDA and other global regulatory agencies.
• Work closely with leadership team members to ensure alignment of regulatory strategies with business objectives.
• Manage and develop a staff of regulatory professionals carrying out product submission / registration activities. Assess resource requirements based on business priorities and allocates personnel as required to meet these objectives. Align right capabilities to challenging tasks and continually monitors and measures with definitive metrics.
• Clearly define and articulate performance goals, with assigned accountabilities, clear decision authority, and an intense focus on alignment.
• Represent Biomeme in interactions / negotiations with U.S. and international regulatory agencies and enables and empowers staff to interact and negotiate with regulators as well.
• Advise, counsel, and actively participate the development of procedures, practices, and systems that ensure compliance with regulatory standards, with particular emphasis on the US FDA’s quality system, medical device reporting, and corrections and removals regulations, European IVD regulation (IVDR), and international medical device standards, including ISO 13485 and ISO 14971.
• Directs the preparation and filing of premarket submissions [510(k)s, de novo submissions, PMAs and Technical Files], and the preparation of content for other ex-U.S. registrations.
• Oversees the regulatory sustaining support to currently marketed products, e.g., review engineering changes, labeling, promotional material, test methods, and other relevant regulatory documentation for compliance with applicable regulatory requirements.
• Monitor and track proposed healthcare-related regulations and standards that will impact the company’s businesses and support regulatory efforts required to comply with new or modified regulations and standards.
• Work closely with the quality and customer service team in the areas of Vigilance, Post Market Surveillance and recalls.
• Prepare relevant technical, safety and performance documents to support submissions in collaboration with other subject matter experts.
• Participate in Continuous Improvement Initiatives to further develop department functions.

Qualifications

Our Story

Biomeme was conceived and created to make the world a better place through the democratization of healthcare diagnostics. To that end, we have created technology that empowers anyone, anywhere (including low-resource settings with minimal space, electricity, and equipment) with the capabilities of a molecular lab in the palm of their hands. Over the last nine years, Biomeme has grown a vertically integrated organization spanning specimen collection, sample prep, assay, and instrumentation R&D, PCR reagent lyophilization, hardware, and consumable manufacturing, as well as molecular diagnostic testing services. With the low cost, ease-of-use, and unparalleled field portability of the Biomeme platform, we are uniquely poised to rapidly advance initiatives in emerging infectious diseases like COVID-19, as well as emergency preparedness, response, and recovery.

Benefits & Compensation

We offer competitive compensation and benefits to meet different employee needs and lifestyles. Benefits include competitive base pay, stock options, 401(k) with dollar-for-dollar match (up to the first 4% of eligible pay contributed), medical, dental, vision, healthcare spending account with dollar-for-dollar company match, basic life insurance, employee and dependent supplemental life insurance, paid time off and paid parental leave.

Biomeme is an Equal Opportunity / Affirmative Action employer committed to inclusion and diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity or any other factor protected by applicable federal, state or local laws.

Biomeme will not discriminate or retaliate against applicants who inquire about, disclose, or discuss their compensation or that of other applicants. Learn more

Biomeme is also committed to working with and providing reasonable accommodations to individuals with disabilities. Please let your recruiter know if you need an accommodation at any point during the interview process.

Biomeme participates in the E-Verify program.

Due to ITAR compliance, this position requires candidates to be a U.S. Citizen, Permanent Resident Alien, or Protected Individual per 8 U.S.C. 1324b(a)(3)

Biomeme is drug-free workplace. Employees are prohibited from manufacturing, distributing, dispensing, possessing, using, or being under the influence of illegal drugs, inhalants, or controlled substances in the workplace. Any employee who violates this policy will be subject to disciplinary action up to and including termination of employment.