Regulatory affairs and product compliance manager

Location Amsterdam
Discipline: Medical Device
Contact name: Gemma Dozy

Contact email: g.dozy@panda-int.com
Job ref: 12261
Published: about 1 month ago

For one of my medical device/FMCG clients in Eindhoven I am looking for a RA Product Compliance Manager. The role is remote, you can be located anywhere in the EU. Initial contract is for 1 year, however longer is preferred.

Ýour job is to ensure that products of Consumer Health Business portfolio comply with external regulations and standards and with company product safety & compliance policies. You will be guiding the business through the borderline and rapidly changing regulatory landscape.

As a member of the central Personal Health RA-SCR team, your job is to ensure that products of Consumer Health Business portfolio comply with external regulations and standards and with company product safety & compliance policies. You will be guiding the business through the borderline and rapidly changing regulatory landscape.

RESPONSIBILITIES:

  • Develop global regulatory strategy, and if needed connect to regulatory SMEs
  • Participate in and advise cross-functional teams on applicable regulations, requirements, and standards, as applicable to products in scope
  • Create product regulatory plan and support creation of standards and compliance plans and labeling plans
  • Elicit regulatory requirements
  • Review development documentation and plans to ensure that the information required for submissions and product compliance is adequate
  • Plan, generate, and coordinate regulatory submissions for product licensing per regulatory plan
  • Coordinate conformity assessment plans required to support regulatory submissions
  • Review and approve product labeling and product related marketing communications
  • Actively monitor changing regulatory environment relevant to the product portfolio with the support of Philips network and external sources
  • Represent RA-SCR in product safety risk management activities


YOUR TEAM:
Central RA-SCR team in it's delegated role of Legal Manufacturer, is accountable for product Safety, Compliance and Regulatory Intelligence for the Personal Health cluster. It owns the related processes and competence and represents the Legal Manufacturer on matters of product regulatory compliance and safety towards competent authorities. Your tasks focus on the support of the new Consumer Health Business Development Teams.

PROFILE: 

  • You have a degree in Software, Electrical, Biomedical or Mechanical Engineering, combined with a strong interest in Regulatory Affairs and Compliance.
  • You have a proven record of accomplishment in product development and Safety & Compliance domains in international, multi-disciplinary development projects (5 years for Master, 7 years for Bachelor).Experience in multiple product regulatory domains (medical device, consumer products, personal protective equipment) is a plus.
  • Proven analytic capabilities and product knowledge and system thinking;
  • A network oriented mind-set and ability to interact with different business functions at all levels
  • Project management skills


YOU ARE:

  • conceptual, analytical, data driven, and also hands-on, getting things done mentality
  • a subject leader and also a team player
  • a good communicator skilled in managing interpersonal processes
  • always looking for perfection and do not accept poor results
  • quality oriented and have a ditto mind-set
  • willing to travel internationally/intercontinentally when needed.
  • fluent in the English language
LOCATION:
  • Netherlands / remote 
 

INTERESTED?

If you’re interested in the above description, please send your CV. 

For further information, please contact Gemma Dozy at +31 (0)20 20 44 502 or by email at g.dozy@panda-int.com