Regulatory Affairs Staff Specialist

**Job Description Summary**: BD Rowa stands for innovative and reliable products related to drug logistics. As a pioneer in automation and digitalization, the company develops and manufactures solutions for pharmacies, hospitals, the pharmaceutical industry and pouch packaging centers at its headquarters in Kelberg (Germany). Worldwide, 800 employees are committed to the competent and reliable customer care. Rowa is part of the global medical device company Becton Dickinson (BD), with whom they share a vision for advancing the world of health.

Your role as Regulatory Affairs Staff Specialist (M/F/d) is to combine knowledge of scientific, regulatory, and business issues to enable product development, manufacture, and life cycle maintenance to ensure compliance with applicable regulatory requirements and technical standards.

You have strong communication and influencing skills to ensure cross-functional teams are engaged in the compliance process. You are detailed in your thinking and have excellent organizational skills allowing you to identify, obtain and gather the required product technical documentation to demonstrate regulatory compliance.

We are seeking an enthusiastic teammate, able to participate with ownership in a complex and fast evolving environment. Experience with CE Marking products under the Machinery, EMC, LVD, RED, RoHS directives or within machinery engineering is desired. Strong knowledge in international standards and regulations including ISO 9001, ISO 13485 is preferred.

Your role will be challenging and diverse, giving you the opportunity to play a key part in supporting the business to achieve our ambitious goals and new markets growth plans.

**Essential Duties and Responsibilities**
- Prepare and maintain product technical files in accordance with applicable EU regulations
- Manage international product registrations according to individual country specific requirements in sync with marketing team objectives
- Support cross-functional product development teams as the regulatory representative in all phases of the product development for new products and for design changes
- Formulate regulatory affairs processes and procedures relating to product compliance in collaboration with cross functional inputs
- Monitor and assess changes in regulations and provide guidance to cross-functional teams to determine their impact and achieve compliance
- Participate to the review of process/product changes, labeling, claims, product complaints, A&Ps (Advertising & Promotional materials), etc., to determine the need for any regulatory action and to ensure compliance to international requirements
- May attend to audits performed by internal and external authorities to represent RA positions and processes

**Essential skills and qualification**
- Sound knowledge of the regulatory framework pertaining to EU Machinery Directive and other EU directives related to CE marking (e.g. EMC, LVD, RED directives), and applicable standards
- Knowledge of EU environmental standards (RoHS, REACH)
- Experience in a design and manufacturing business of machines
- Strong English and German communication skills
- BSC or equivalent in engineering or scientific discipline
- +3 years' experience in similar role preferred

**Our Offer**

A professional challenge in a highly motivated team, a global environment and with long-term perspectives. A familiar working atmosphere in an innovative environment where your opinion matters. Diversity characterizes our corporate culture and we are convinced that it makes us a stronger team. We value each person as an individual with their abilities and needs. In this sense, we welcome applicants who wish to work part-time, people with severe disabilities and applicants of any gender.

We endeavor a long-term collaboration - hence corporate career planning throughout diverse phases of life conveys a high importance and value for us.

The approx. annual gross salary for this position is € 70.000;
- (full-time basis), depending what country your residence is. Based on individual skills and experience, we offer appropriate additional payment.

Our modern office is located in the Millennium Tower with excellent traffic connection. BD offers flexible working time, home office, a stock ownership program and numerous social benefits (e.g. free drinks, massage and Sodexo-childcare vouchers). You will be part of a committed team; your position will include a varying area of duties as well as personal development opportunities.

**Primary Work Location**: DEU Kelberg - Rowastrasse