Regulatory Affairs Manager
vor 2 Monaten
We have an exclusive mandate for one of our clients in Medical Devices based in Canton of Neuchatel.
As a Regulatory Affairs Manager, you will be responsible for:
- Support new product development by using in-depth knowledge and understanding of US domestic and international medical device, regulations (including 510k, and International dossiers)
- Lead and mentor a focused team to ensure that the product portfolio and the required regulatory documentation is optimized for the business.
- Manage the development of US and International regulatory strategies and verification and validation activities for assigned product submissions.
- Author submissions (510k, MDR files, MDD changes) independently. Ensure timeliness of regulatory submissions according to business needs.
- Actively lead and/or manage the regulatory aspects of upcoming audits and certification reviews with all Company designated Notified Bodies.
- Identify strategies to ensure compliance and maintenance of Regulatory Affairs product files (design dossiers, periodic regulatory reports) to support compliance with regulatory requirements.
- Develop regulatory strategies and internal processes around ad/promo reviews based on regulations; Provide expert guidance to teams and oversee review of promotional and advertising material for adherence to approved product claims and regulatory compliance.
- Manage RA leads as well as manage partnership with Product Development, Manufacturing and QA/QC to ensure overall compliance with US, Canadian, European, and International regulations.
- Manage rollouts of product changes with corporate and international regulatory teams.
- Manage the planning and coordination of rollouts of product changes with corporate and international regulatory teams.
- Provide oversight and work with cross-functional management to review and approve rework of non-conforming product CAPA, SCAR, HHE and Field Actions. Support product risk management in accordance with FDA/ISO 14971.
- Manage the regulatory review of complex Change Engineering Requests, Document Change Requests, Variances, and other Quality System Documentation that requires regulatory review and approval to ensure compliance with government regulations.
- Manage and establish labelling requirements per regulations and review labelling that requires regulatory review and approval to ensure compliance with government regulations
- Lead and participate in continuous improvement projects within Regulatory Affairs and throughout the organization.
Your profile:
- Bachelor’s degree in Science, Engineering, Regulatory Affairs, or other technically related field.
- ** Minimum of 4 years in Regulatory Affairs working in an FDA regulated industry in the Medical Devices**:
- Strong experience in working effectively with cross-functional teams and provide regulatory input
- **Experience working with FDA locally and nationally.**:
- ** Expert applied knowledge of domestic and/or international medical device regulations including 510k and international dossier submissions**:
- Strong applied understanding of business strategies and tactics, including an understanding of regulatory impact.
- Proven experience in effectively communicating and working with US FDA, European Notified Bodies, Competent Authorities, and other regulatory agencies.
- ** Proven skills in the planning, management, and approval of CE registrations and US 510(k)**:
- Must have strong data analysis, technical writing, project management and communication skills.
- Demonstrated skills handling multiple demanding projects and in contributing to multiple projects simultaneously.
- Develops proposals for solutions and applies solutions to identified issues.
- Develops plans to meet pre-defined Regulatory goals.
- Willingness to take ownership and accept responsibility for actions and decisions.
BOOST
-
Regulatory Affairs Manager
vor 4 Wochen
Basel, Schweiz headcount AG VollzeitBereit, die Verantwortung für Ihr Portfolio zu übernehmen? Unser Kunde, ein etabliertes Unternehmen mit einem Portfolio von Generika- und Neuro-Produkten, benötigt Ihre Hilfe, um Exzellenz im Lifecycle-Management ihrer Produkte auf dem lokalen Markt zu erreichen. Sie werden die Führung übernehmen und eng mit der Zentrale in Deutschland zusammenarbeiten,...
-
Regulatory Affairs Manager
Vor 2 Tagen
Basel, Schweiz CPL Recruitment Vollzeit**Posted date **15 April 2024 **Location**Basel **Job type** Permanent **Salary**Negotiable **Discipline** Life Sciences **Reference**JO-2404-533260 **Work Location** Hybrid An exciting and growing business looking to bring state-of-the-art medical technology to the market, enabling people globally to self-manage diabetes and other chronic diseases,...
-
Regulatory Affairs Manager
vor 3 Wochen
Basel, Schweiz Proclinical VollzeitProclinical are working alongside a pharmaceutical organisation who are recruiting for an individual to join their team. This role is on a contract basis. The opening position is for a Regulatory Affairs Manager. For more information, please get in touch now! **Responsibilities**: - Conduct regulatory evaluations for aberrations and change control. -...
-
Senior Manager Regulatory Affairs
vor 2 Monaten
Basel, Schweiz Veristat VollzeitDescription : Senior Manager Regulatory Affairs Would you like to join and contribute to a successful and growing multi-national organization in the heart of Europe and one of the world’s leading regions of the pharmaceutical industry? SFL, a Veristat company, and its dynamic cross-functional team provide premium consulting support to companies...
-
Senior Regulatory Affairs Manager
vor 3 Wochen
Basel, Schweiz Veristat VollzeitJob Description : Senior Regulatory Affairs Manager Would you like to join and contribute to a successful and growing multi-national organization in the heart of Europe and one of the world’s leading regions of the pharmaceutical industry? SFL, a Veristat company, and its dynamic cross-functional team provide premium consulting support to...
-
Senior Regulatory Affairs Manager
vor 1 Woche
Basel, Schweiz Veristat VollzeitJob Description : Senior Regulatory Affairs Manager Would you like to join and contribute to a successful and growing multi-national organization in the heart of Europe and one of the world’s leading regions of the pharmaceutical industry? SFL, a Veristat company, and its dynamic cross-functional team provide premium consulting support to...
-
Regulatory Affairs Manager
Vor 4 Tagen
Basel, Schweiz Proclinical VollzeitProclinical are recruiting a Regulatory Affairs Manager - CMC for a pharmaceutical organisation. This role is on a contract basis and is located in Basel. *** **Responsibilities**: - Offer regulatory assistance for projects and project teams. - Write, evaluate and offer contribution from a CMC perspective on pertinent documents necessary for clinical...
-
Regulatory Affairs Manager
vor 1 Monat
Basel, Schweiz Lonza VollzeitSwitzerland, Basel - Switzerland, Visp**Randstad Inhouse Services** is looking for a Regulatory Affairs Manager (M/F/d) for **Lonza AG** in Basel (100%). This is a **temporary **position for 12 months with an opportunity for an extension. Today, Lonza is a global leader in life sciences operating across three continents. While Lonza works in science,...
-
Regulatory Affairs Manager
Vor 4 Tagen
Basel, Schweiz ProClinical Vollzeit**Salary**: Highly Competitive Job type: PermanentDiscipline: Project Manager**Location**: Switzerland- Basel, Schweiz - Posting date: 27 Feb 2024 Reference: 57992 Proclinical are recruiting for a Regulatory Affairs Manager - EMEA to join a pharmaceutical organisation. This role is on a permanent basis and is located within the EMEA with the ability to...
-
Regulatory Affairs Manager
Vor 7 Tagen
Basel, Schweiz CTC Resourcing Solutions Vollzeit**The Life Science Career Network** Our client is a leading global player in the Pharmaceutical industry with global headquarters in Basel, Switzerland. They are undergoing a transformation with respect to culture and outside perception. The organisation focusses on novel therapies in Oncology and Ophthalmology and is also currently developing a...
-
Regulatory Affairs
vor 2 Monaten
Basel, Schweiz LGT VollzeitDie LGT ist die weltweit grösste Private Banking und Asset Management Gruppe im Besitz einer Unternehmerfamilie. Als Family Office des Fürstenhauses von Liechtenstein überzeugen wir Sie mit langjähriger Erfahrung in der Verwaltung grosser Vermögen. Stellenbeschreibung Für unsere langfristige Weiterentwicklung im Intermediär-Geschäft übernehmen Sie...
-
Manager, Regulatory Affairs Emea
vor 2 Wochen
Basel, Schweiz Ultragenyx Pharmaceutical Vollzeit**Why Join Us?** - Be a hero for our rare disease patients_ Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth - so employees can thrive in all areas of their lives, in and outside...
-
International Regulatory Affairs Manager
Vor 6 Tagen
Basel, Schweiz Sobi Vollzeit**Company Description** Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere. One...
-
Regulatory Affairs Cmc Associate Manager
vor 1 Monat
Basel, Schweiz Manpower Vollzeit**For our client, a leading pharma company in Basel, we are looking for a Regulatory Affairs CMC Associate Manager to start asap.** **Your mission** As Associate Manager within our Global Regulatory Affairs CMC team, you support timely preparation of high-quality CMC (Chemistry, Manufacturing, and Control) regulatory documentation for our products and...
-
Regulatory Affairs Manager
vor 2 Monaten
Basel, Schweiz unisite AG VollzeitDie Gesundheit und die Lebensqualität von Patienten zu verbessern, ist das Ziel des forschenden Pharmaunternehmens Boehringer Ingelheim. Seit der Gründung im Jahre 1885 in Familienbesitz, zählt Boehringer Ingelheim zu den 20 führenden Unternehmen der Branche. Für die drei Geschäftsbereiche Humanpharmazeutika, Tiergesundheit und Biopharmazeutika...
-
Regulatory Affairs Cmc Associate Manager
vor 1 Monat
Basel, Schweiz Manpower Suisse Vollzeit**For our client, a leading pharma company in Basel, we are looking for a Regulatory Affairs CMC Associate Manager to start asap.** **Contract duration**: 18 months with extension possible **Workload**:100% **Location**: Basel city **Description**: As Associate Manager within our Global Regulatory Affairs CMC team, you support timely preparation of...
-
Quality & Regulatory Affairs Manager
Vor 2 Tagen
Basel, Schweiz Manpower Vollzeit**Your mission** To strengthen their team, they are looking **for a Quality & Regulatory Affairs Manager (80% - 100%). based in Neuchâtel.** **Tasks are the following**: **Quality Management** - Further development and implementation of quality management - Deputy to the Quality Management Representative - Conduct internal audits as per audit program -...
-
International Regulatory Affairs Intern
vor 2 Wochen
Basel, Schweiz Mirum Pharmaceuticals Vollzeit**MISSION**: **Job Summary**: As an Intern in Regulatory Affairs International team, you will work closely with the regulatory affairs team to ensure compliance with applicable regulations, standards, and guidelines governing the development, manufacturing, and marketing of pharmaceutical products. This entry-level position provides an excellent opportunity...
-
Regulatory Affairs Associate Cmc Manager
vor 1 Monat
Basel, Schweiz Source Group International VollzeitPosted: - Today- Location: - Basel, Switzerland- Job Ref: - BH-34786- Job Type: - Contract- Salary: - CHF40 - CHF44 per hour- Expiry date: - 1/18/2023- Contact: - Audwin Cheung- Xplore Life Sciences are recruiting for an Associate Regulatory Affairs CMC Manager to work for a Global Leader in Pharmaceuticals based in Basel. This is an 18 Month freelance...
-
Regulatory Affairs Manager
vor 1 Monat
Basel, Schweiz BÜHLMANN Laboratories AG Vollzeit**BÜHLMANN Laboratories AG **ist eine international tätige und innovative Produktions - und Handelsfirma im Bereich Life Sciences. Das Unternehmen mit Hauptsitz in Schönenbuch beschäftigt mehr als 120 Mitarbeitende und ist global aktiv. Die selbst entwickelten und hergestellten diagnostischen Kits und Reagenzien werden weltweit als **in vitro...