Regulatory Affairs Manager EMEA - Uppsala, Sweden at Johnson &… · Zug

Regulatory Affairs Manager EMEA - Uppsala, Sweden Location: Uppsala, Sweden At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: Professional All Job Posting Locations: Uppsala, Sweden, Zuchwil, Switzerland, Zug, Switzerland Job Description: About Vision Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding on the possibilities of vision treatments? Ready to join a team that’s reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs – from the pediatric to aging eye – in a patient’s lifetime. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech. Regulatory Affairs Manager EMEA Vision Care – Uppsala, Sweden We are now looking for a Regulatory Affairs Manager to join our Vision Care organization in Uppsala, Sweden. In this influential role, you will play a vital part in enabling safe, compliant, and timely access to innovative medicinal products and medical devices across the EMEA region. You will work closely with regional and global stakeholders, contributing your regulatory expertise to support product launches, lifecycle activities, and continuous improvement in a highly regulated and impactful environment. Please note that a pre-identified candidate for consideration has been identified. However, all applications will be considered. Objectives of the Position Regulatory Strategy & Compliance Apply scientific, regulatory, and business knowledge to ensure compliance for medicinal products and medical devices throughout their life cycle Ensure adherence to European regulations (including MDR) and applicable national EMEA requirements Regulatory Submissions & Registrations Prepare, assemble, and submit regulatory applications to Competent Authorities and Notified Bodies to achieve and maintain product registrations within EMEA Prepare, review, and approve registration dossiers, technical documentation, and labeling materials (e.g. package inserts) prior to submission Change Control & Lifecycle Management Participate in site change control processes and ensure regulatory impact assessments are received and properly filed from all global regions Manage and submit regulatory change notifications and approvals to authorities prior to implementation Collaboration & Regional Support Work closely with the Director, Regulatory Affairs EMEA, to support regional regulatory projects and initiatives Provide Regulatory Affairs support for local registrations and market authorizations in individual EMEA countries Support other regional RA teams relying on European registrations Manufacturing, Audits & Distribution Ensure regulatory distribution release activities for medical device products Support inspections and audits by Competent Authorities and Notified Bodies at manufacturing sites, focusing on RA‑related aspects Ensure labeling and packaging compliance for both new and existing products Qualifications & Experience Education University degree in Life Sciences, Pharmacy, Medical device Engineering, or another relevant scientific discipline Experience Strong regulatory knowledge especially in EMEA medical / medical Device products regulations and ideally experience in CE marking of medical devices (class IIa and above; for 4-6 years); experience with CE marking of ophthalmic medical devices is of advantage. Managerial responsibility (at least 2 years) – including supervisor responsibility Hands‑on experience with regulatory submissions to Competent Authorities and/or Notified Bodies Solid understanding of European regulatory frameworks, including MDR Experience supporting product lifecycle management and change control processes Skills & Competencies Strong analytical skills and attention to detail Ability to manage regulatory activities in a complex, cross‑functional, and international environment Clear and confident communication skills, both written and verbal Comfortable working independently while collaborating closely with regional and global stakeholders Fluent in English both written and verbal (Swedish is advantage) Required Skills: Preferred Skills: Analytical Reasoning, Business Writing, Coaching, Compliance Risk, Fact-Based Decision Making, Industry Analysis, Legal Support, Process Improvements, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Strategic Thinking, Technical Credibility The anticipated base pay range for this position is: kr614,000.00 - kr1,059,150.00 Benefits: In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers. *This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change. Additional Locations: Zuchwil, Switzerland, Zug, Switzerland