Associate Director, Regulatory Affairs - Digital Health, Device & Combination Products (all gender)
About this opportunity
Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
Your Role: In this pivotal role, you will own and drive the global regulatory strategy for drug-device combination products, shaping the pathway from early development through to approval and lifecycle management. You will serve as the Device Regulatory Lead within a cross-functional regulatory strategy team, working in close partnership with CMC, device engineering, and quality colleagues to ensure compliant, timely, and scientifically credible submissions to health authorities worldwide. Your ability to build trusted relationships with regulatory agencies and to translate complex regulatory requirements into clear, actionable strategies will be central to accelerating the development of innovative combination products. Operating with considerable autonomy, you will influence both internal decision-making and external regulatory outcomes, contributing to a culture of regulatory excellence and risk-based thinking across the R&D organization.
Who You Are:
You hold a degree in a life science or related discipline (MSc minimum or equivalent); a higher degree such as a PhD in a scientific discipline is preferred.
You bring 10 or more years of regulatory affairs experience, with proven and recent expertise in drug-device combination product submissions and/or medical devices for US, EU, and international markets.
You have a demonstrated ability to develop global regulatory strategies and assemble dossiers for submissions including EU MAA, NBOp, CTA, US IND, NDA, BLA for combination products, 510(k), and PMA; international experience is strongly preferred.
You have a proven track record of productive collaboration with regulatory authorities through scientific advice meetings, and you are able to act as a credible, influential spokesperson during such interactions.
You possess a solid understanding of the drug-device combination and medical device regulatory framework across EU, US, and international markets, including ICH, EU-MDR, MDSAP, ISO 13485, cGMP for combination products, QMS, technical file requirements, eCTD, and MCDG guidelines.
Prior experience with regulatory CMC and connected drug-device combination products for medicinal products is an advantage.
You are a strong team player who thrives in a highly multidisciplinary environment and communicate effectively with colleagues and stakeholders from diverse professional backgrounds.
You are fluent in English; proficiency in additional languages is an asset.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
Job details
How this role compares
Computed from every other active Regulatory Affairs role in our database, not just this employer's listings.
We currently track 220 comparable Associate Director Regulatory Affairs roles across 65 biopharma companies.
Salary context
58 of 220 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 220 comparable roles
+ 28 more countries
Seniority mix
220 of 220 peers have a known seniority level
Therapeutic area mix
16 of 220 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
Notify me about similar jobs
Get an email when we spot other openings like this one – same job function, comparable seniority, roles you'd actually want to see.
How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.