Director, Regulatory Affairs, Precision Medicine & Digital Health
Stryker Corporation, Indianapolis, IN, United States
Position Summary
You will lead regulatory strategy for precision medicine and digital health across respective regions. You will work with scientific, clinical, digital and commercial teams to design and deliver regulatory plans that enable safe, effective and compliant development. We value strategic thinking, clear communication, and collaborative leadership. This role offers visible impact, career growth, and the chance to help unite science, technology and talent to get ahead of disease together.
Please note: This position requires an on-site office –based presence 2 to 3 days a week in the US (MA, MD, PA or NC); UK (London or Stevenage); or Poland (Warsaw) office.
Responsibilities
Lead development and execution of regional regulatory strategies for precision medicine and digital health assets.
Coordinate regulatory interactions with local and regional health authorities and external partners.
Provide regulatory input to cross-functional project teams from early development through lifecycle management.
Ensure regulatory compliance for companion diagnostics, software as a medical device (SaMD), and digital health components.
Interpret regulatory feedback and translate it into clear operational plans and submission materials.
Mentor and coach colleagues to build regulatory capability across the business.
Basic Qualifications
Bachelor's degree in biological science, healthcare science, engineering or equivalent.
Experience working in the pharmaceutical industry, MedTech industry or regulating authorities.
Practical experience with regulation of companion diagnostics and/or SaMD.
Proven track record leading development, submission and approval activities in one or more regions.
Experience preparing for and leading regulatory milestone meetings and authority interactions.
Strong written and verbal communication skills and ability to work in a matrix environment.
Preferred Qualifications
Advanced degree (MSc, MS, PhD, MD or equivalent) in a relevant discipline.
Deep knowledge of clinical trial and licensing requirements for precision medicine and digital health across major markets.
Experience influencing senior stakeholders and advocating regulatory positions.
Proven ability to build strong cross‑functional networks and external relationships.
Practical experience assessing in‑licensing opportunities involving diagnostic or digital components.
Experience coaching or developing junior regulatory professionals.
Benefits The role offers an annual base salary commensurate with experience and location, a performance bonus, and eligibility for a share‑based long‑term incentive program. Benefits include health insurance, retirement plans, paid holidays, vacation, and paid caregiver/parental leave.
Equal Opportunity Employer GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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Please note: This position requires an on-site office –based presence 2 to 3 days a week in the US (MA, MD, PA or NC); UK (London or Stevenage); or Poland (Warsaw) office.
Responsibilities
Lead development and execution of regional regulatory strategies for precision medicine and digital health assets.
Coordinate regulatory interactions with local and regional health authorities and external partners.
Provide regulatory input to cross-functional project teams from early development through lifecycle management.
Ensure regulatory compliance for companion diagnostics, software as a medical device (SaMD), and digital health components.
Interpret regulatory feedback and translate it into clear operational plans and submission materials.
Mentor and coach colleagues to build regulatory capability across the business.
Basic Qualifications
Bachelor's degree in biological science, healthcare science, engineering or equivalent.
Experience working in the pharmaceutical industry, MedTech industry or regulating authorities.
Practical experience with regulation of companion diagnostics and/or SaMD.
Proven track record leading development, submission and approval activities in one or more regions.
Experience preparing for and leading regulatory milestone meetings and authority interactions.
Strong written and verbal communication skills and ability to work in a matrix environment.
Preferred Qualifications
Advanced degree (MSc, MS, PhD, MD or equivalent) in a relevant discipline.
Deep knowledge of clinical trial and licensing requirements for precision medicine and digital health across major markets.
Experience influencing senior stakeholders and advocating regulatory positions.
Proven ability to build strong cross‑functional networks and external relationships.
Practical experience assessing in‑licensing opportunities involving diagnostic or digital components.
Experience coaching or developing junior regulatory professionals.
Benefits The role offers an annual base salary commensurate with experience and location, a performance bonus, and eligibility for a share‑based long‑term incentive program. Benefits include health insurance, retirement plans, paid holidays, vacation, and paid caregiver/parental leave.
Equal Opportunity Employer GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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