Regulatory Quality Manager (MUST apply via Lever)

TL;DR:

Legacy (YC S19) is a Series B startup focused on the fast-growing field of fertility and family planning. Founded at Harvard three years ago, the company has raised close to $50M from leading investors like FirstMark Capital, Bain Capital Ventures, Section 32, and celebrities like Justin Bieber. The company has raised 4 rounds of venture funding in 2.5 years. Today, Legacy is the category leader, working with major insurers, major employers, and the military, in addition to its D2C offering.

What do we do?

We are building a complete digital health hub for future parents. We aim to change the outdated view that fertility is a "women's issue" by creating an accessible, affordable product for men. This includes everything from a mail-in kit for sperm testing & sperm freezing, personalized sperm improvement products, tele-health, DNA fragmentation analysis, supplements, and more.

Description

We are looking for our first dedicated regulatory quality manager to support our operations, regulatory, and research teams and coordinate the FDA compliance function. The ideal candidate will advise leadership and stakeholders on all compliance matters related to the company, with a particular focus on supporting FDA submissions and listings, maintaining, and improving the internal Quality Management System (QMS), and ensuring that our research endeavors are held to the highest regulatory standards. This position will report to our Chief Operating Officer, who oversees our business operations, legal, human resources, and finance functions, and this role will be an integral part of the team. Title and compensation will be commensurate with experience level.  

Responsibilities

• Develop and implement Legacy’s compliance strategy in line with ISO 13485 standards, CLIA, and other regulatory regimes

• Maintain and update internal QMS, including thorough self-assessments, internal audits, and enterprise-wide training programs

• Follow up on concerns identified, conduct investigations as necessary, ensure that appropriate actions taken

• Serve as resource for all compliance questions from leadership regarding laboratory operations, quality management architecture, and specific marketing claims

• Develop and disseminate standardized tools and resources and education and training programs to support laboratory compliance and operational policies and procedures

Qualifications

• A minimum of 5 years’ experience in medical device compliance and/or quality management/improvement settings

• Bachelor’s degree from accredited university

• Excellent written and verbal communication skills

• Strong personal diplomacy skills with demonstrated ability to handle sensitive communications with leadership, employees, contractors, and partners

• Excellent capacity to collaborate and coordinate across multiple teams

• Demonstrated mastery of compliance counselling with ISO 13485 standards, CLIA, and other applicable statutes

• Proven track record of:

o Successful project execution

o Strategy development and implementation

o Resource recruitment, training and management

• Ability to rapidly detect operational roadblocks and propose solutions

• Strong organizational skills and attention to detail

• Fast thinker and ability to act promptly to solve issues that mitigate risk

Why should you join us?

Look, there's lots of reasons to join any high-growth startup. "Get on a rocket ship" blah blah blah. If you're the kind of candidate we're looking for, then you already know this. Here are a few other reasons you might not already know:

We're a team of under 50 people , despite being at the Series B stage. You will be one of the first 50 employees and will profoundly impact where the company goes in the coming years.

Everyone thinks about becoming a parent. You will help couples on their journey to creating a family. You will help push society towards a fairer, more equitable place. You will be a trusted resource for men and women at the most intimate moment in their lives, including heterosexual couples, LGBTQ+ couples, and individuals who are thinking about how and when they'll want to have a family in the future.

We will invest in you like you wouldn't believe. Every single hire gets an executive coach. You'll get training for anything you need. We'll give you an unlimited 'Health & Wellness' stipend where we pay for 75% of anything you deem might improve your life (Mattresses, Pelotons, etc.) You'll have a 'buddy'. We'll set you up with a charity and match your contributions. And we will talk about your careers goals, aspirations, and feelings every single week.

(Oh - and of course you'll get the same health care, 401K, unlimited time off, and other perks that any serious company offers its team members today.)

Ultimately, we are here to win, and we believe that the best way to win is to help everyone bring their absolute best self to work. So our job is to help you be the best personal and professional version of yourself that you want to be.