Regulatory Affairs Specialist, Medical Device
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ABOUT ABBOTT
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
WORKING AT ABBOTT
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:
Career development with an international company where you can grow the career you dream of.
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
Main Purpose of Job:
Responsible for activities which lead to and maintain regulatory approval to market devices. Works with various stakeholders such as labeling / global team for launch readiness.
Develops and implements strategies for earliest possible approvals.
Ensures timely preparation of submissions. Builds rapport with regulatory agencies. Anticipates regulatory environment change and manages the regulatory intelligence for new policy, regulation etc. as required.
Key Responsibilities:
Manage the regulatory approval or registration of medical devices and license maintenance.
Develop registration strategies, prioritizing assignments, implementing regulatory plan, and coordinating multiple projects and activities in accordance with strategic company objectives, submission plan and targets.
Research and monitors regulatory requirements for assigned geographies / competent authority
Monitor requirements of related medical device laws & regulations
Cultivation of professional working relationships with competent authorities and local medical device industry association
Review and approval of A&P materials to ensure compliance with local regulations.
Ensure proper documentation and record management of submission, approvals, certificates as required.
Handle/supports regulatory related processes or projects, e.g. labeling project, PRA process
Qualifications / Education Required:
Diploma, Advanced/Higher/Graduate Diploma, Bachelor’s degree or equivalent, preferrably in pharmacy, health sciences or related science background
Skills and Experience:
2 years experience in Medical Device Regulatory Affairs preferred.
Proficient in Microsoft Office applications especially excel files.
Effective interpersonal, communication and analytical skills
Proficiency in written and spoken English and Local language.
Independent. Highly result oriented; ability to deliver and overcome obstacles.
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 524 comparable Regulatory Affairs roles across 111 biopharma companies.
Salary context
128 of 524 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 524 comparable roles
+ 41 more countries
Seniority mix
419 of 524 peers have a known seniority level
Therapeutic area mix
50 of 524 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.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Open in 2 locations
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
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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.