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