Manager - Regulatory Affairs (5-10 yrs)
The responsibilities we'll trust you with :
- Developing the regulatory strategy for multiple products across US, EU, India, South East Asia and other geographies.
- Managing the activities of Regulatory Affairs, ensuring the implementation of appropriate and effective regulatory strategies.
- Oversees quality efforts in the organization and planning training for the team to ensure everyone is updated with current regulations.
- Building a strong team, managing and being responsible for QAs and technical writers.
- Developing, implementing, and reviewing SOPs, providing regulatory input to product lifecycle planning.
- Planning and implementing trials and regulatory inspections, keeping up-to-date with changes in regulatory legislation and guidelines.
- Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions.
- Developing functional annual operating budgets for Regulatory Affairs to meet long-term company and department objectives.
- Conducting regular internal audits to emphasize on preventive measurements and face external audits from regulatory agencies.
Looking for someone with :
- 5-8 years of experience working in the medical device or related industry with direct extensive experience leading a team in Regulatory Affairs.
- Knowledge of Medical/Technical writing, Advertising and promotion, Labelling,
Controlled substances, standards, Import / export, quality assurance, and Country specific regulatory support.
- Extensive knowledge and experience of U.S. and/or European/International regulations and standards, such as
- ISO 13485, ISO 14971
- 21 CFR Part 820
- IEC 61010,IEC 62304, IEC 62366,
- ISO 15197, ISO 15223,
- EU MDR and EU IVDR
- Along with CE Certification and Surveillance audits
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.