Manager, Regulatory Affairs

☞ Masimo

View: 154

Update day: 25-04-2024

Location: Neuchâtel Neuchâtel NE

Category: Legal / Contracts

Industry: Medical Equipment Manufacturing

Position: Mid-Senior level

Job type: Full-time

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Job content

Job DescriptionIn this role, the Manager, Regulatory Affairs – Europeyou will be an integral part of the regulatory affairs team that is responsible for providing input to support in the strategic and organizational direction of the regulatory affairs department. in this role you will be responsible for providing direction and leading the regulatory affairs team in the maintaining and documenting of international regulatory filings and registrations in Europe and parts of Africa. The role is responsible for supporting and providing input in the direction and guidance for the obtaining and maintaining of regulatory approvals to support the corporation’s global commercial distribution goals. You will also be required to provide guidance on the regulatory strategy for new products under development for Europe and parts of Africa. You will exercise sound and strategic judgment in determining appropriate regulatory actions and requirements/directions for new product or product changes and in the preparation of regulatory documents. You should be able to provide medical device regulatory leadership expertise, organizational ability, and multi-tasking skills.You will be based in our International Headquarter based in Neuchâtel, this role is a 100% office based.Duties & Responsibilities
  • Provide management and leadership to the Regulatory Affairs organization in the development and implementation of regulatory strategies and processes for Europe;
  • Responsible for Company’s Regional Regulatory filings, and obtaining the required regulatory approvals to market the Company’s products;
  • Ensure compliance to the Swiss Medical Devices Ordinance requirements as Swiss Authorized Representative for designating entities and for imported medical devices.
  • Act as Person Responsible for Regulatory Compliance for the Swiss Authorized Representative.
  • Represent Regulatory Affairs on project teams and management review meetings;
  • Review advertising, labeling, and public communications for regulatory compliance issues;
  • Assist in developing regulatory strategy for new products and claims;
  • Responsible for keeping management team informed of regulatory status of products and significant regulatory issues;
  • Maintain current knowledge on regulatory requirements.
  • Provide counsel, training, and interpretation of regulatory requirements to Company personnel and assist as a liaison between the Company and regulatory authorities;
  • Assist in ensuring compliance to the Medical Device Regulation (MDR) in the EU, and other regulatory requirements;
  • Support QA and QC in developing and executing compliance activities and corrective actions involving regulatory authorities;
  • Direct, plan, delegate and manage department budget and staff
Minimum Experience
  • Minimum 5 years of professional experience in Regulatory Affairs or in Quality Management Systems relating to medical devices;
  • Must know regulatory requirements for CE-marked medical devices and medical device requirements for Switzerland;
  • Experienced in FDA QSR requirements and ISO 13485 requirements;
  • Experienced in international regulatory filings;
  • Excellent communication skills, both verbal and written, and the ability to interface effectively with engineering, manufacturing, sales and marketing, administration and external stakeholders;
  • Good conceptual, analytical, problem solving, and organizational skills;
  • A “hands-on” individual, who enjoys challenge, is capable and dedicated to getting the job done with minimal support and direction;
  • An assertive, take-charge, proven manager with a strong results orientation, positive “can do” attitude, and a sense of urgency to get things done;
  • Ability to use common sense and judgment, to build, motivate and manage a strong regulatory organization;
  • Well-organized and accustomed to maintaining excellent records.
Preferred Experience
  • Experience in patient monitor systems, hospital-based products, software, or electronic device products;
  • Minimum 3 years of managerial experience in Regulatory Affairs activities, or related field.
EducationBachelor’s degree is required, preferably in life sciences, engineering, law, medicine, pharmacy, or another relevant scientific discipline. Graduate degree in a technical discipline or business management is preferred.Are you looking for uncommon opportunities with an extraordinary company?We are looking for people who can, do and will make a difference. Are you interested to hear more about this position?To learn more about us, please visit: www.masimo.com
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Deadline: 09-06-2024

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