Director of Regulatory Affairs

July 26

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BillionToOne

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We push the boundaries of molecular diagnostics through quantitative technologies.

201 - 500

💰 $35M Debt Financing on 2022-12

Description

• Develop and implement global strategies to secure market approval for products • Manage key Quality Management System processes to ensure compliance with regulations • Anticipate new regulations and coordinate with stakeholders for compliance • Engage with cross-functional teams for regulatory initiatives from requirements gathering to approval

Requirements

• Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology or related subject) • Relevant advanced degree is preferred • Regulatory Affairs Certification (RAC) a plus • 5+ years of regulatory experience. Some portions should include relevant exposure to PMA regulatory work • Proven 3-5 years in a leadership role with strong management skills • Experience interfacing with government regulatory agencies and Health Authority • Strong communication and verbal skills • Detail oriented with well-developed organizational and analytical skills • Creative problem solving, flexibility, and good negotiation skills are a must • Ability to drive results to established timelines and on budget • Experience managing remote business activities • Must be comfortable and effective acting as a catalyst for change • Must be performance and results oriented and be able to develop, motivate and lead effective teams • Hard driver, high energy, positive attitude, works well under stress and with ambiguity • 25% travel required

Benefits

• Working with a team of ‘rockstars’ who bring out the best in everyone • Open, transparent culture that includes weekly Town Hall meetings • The ability to indirectly or directly change the lives of hundreds of thousands patients • Multiple medical benefit options; employee premiums paid 100% of select plans, dependents covered at 80% • Extremely generous Family Bonding Leave for new parents (16 weeks, paid at 100%) • Retirement savings program including a 4% Company match • Free daily on-site lunches provided from top eateries • Latest and greatest hardware (laptop, lab equipment, facilities) • A variety of perks on campus (state of the art gym, restaurant) • Free on-site EV charging (compatible with all EVs, including Tesla)