14 часов назад
Regulatory Affairs & Quality Lead (Region Europe)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Regulatory Affairs & Quality Lead (Region Europe) (medical devices): Leading regional regulatory affairs, submissions, compliance, and quality systems for precision radiation medicine products with an accent on European medical device regulations, regulatory strategy, and cross-functional alignment. Focus on coordinating authority interactions, approving compliant product releases, improving quality processes, and developing regional teams.
Location: Stockholm, Sweden; four days per week on-site
Company
develops precision radiation medicine and radiotherapy solutions used by healthcare providers in more than 130 countries.
What you will do
- Lead and coordinate regulatory affairs and quality activities across Region Europe.
- Define regional priorities and align regulatory and quality goals with global strategies.
- Drive regulatory submission strategies, maintain the regulatory roadmap, and coordinate submissions.
- Represent with regulatory authorities and industry organizations while supporting local teams.
- Establish, maintain, and improve regional processes, procedures, and quality systems.
- Approve regulatory and quality documentation, support compliant product release, manage operational planning, and mentor team members.
Requirements
- Proven Regulatory Affairs experience in the medical device industry.
- Strong knowledge of European medical device regulations; familiarity with US FDA regulations is advantageous.
- Experience with quality systems, supplier quality, manufacturing engineering, regulatory submissions, and regulatory authority interactions.
- Leadership, team development, stakeholder management, and cross-functional alignment skills.
- Knowledge of quality tools and methodologies, budget management, and operational planning.
- Degree in engineering or a related field, or equivalent experience; proficiency in Microsoft Office applications.
Nice to have
- ISO Auditor experience.
- Experience working in a multicultural, international environment.
Culture & Benefits
- Collaborative office environment with four days per week on-site.
- 30 paid vacation days per year plus four additional days off.
- Defined contribution pension scheme and private medical insurance.
- Lunch benefit and contribution to wellness activities.
Hiring process
- Submit a CV in English through the application portal.
- Applications are reviewed on an ongoing basis.
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